form 6-a punjab import (list 4) 6-a punjab.… · punjab s. no name and addresses of ... gyeonggi...

"Following is the provisional list of applications received for provisional enlistment of products on FORM-6A with the Division of Medical Devices & Medicated Cosmetics, Drug Regulatory Authority of Pakistan, Islamabad under provision of SRO 32(I)/2018 dated 16-01-2018. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application.

DISCLAIMER:

The contents of this list shall not be used as reference for any purpose including litigation, claim, right, research, citation, statistical analysis, etc and are for information only. Errors and omissions are accepted and at provisional stage the DRAP shall not be responsible for any legal claim and liability"

APPLICATION FOR THE GRANT OF REGISTRATION OF CLASS A MEDICAL DEVICES

FORM. 6A PUNJAB

S. No Name and Addresses of Establishment

Manufacture Details Name of Medical Device with Sizes/Class/Shelf Life

Brief Description R &I Detail

1 M/s. Asto Life Sciences. 44/1.K Block Model Town Lahore. ELI‐00103

Legal Manufacturer M/s. Becton, Dickinson and Company, 1 Becton Dr Franklin Lakes, NJ USA 07417 Manufacturer: M/s. Becton Dickinson & Co. 150 S 1st Ave, Broken Bow, NE USA 68822 FSC USFDA Valid till June 20, 2019

BD Vacutainer® Plus EDTA Tubes (2.0ml, 3.0ml, 4.0ml, 10ml) ‐ BD Vacutainer® Plus Citrate Tubes (1.8ml, 2.7ml, 4.5ml) ‐ BD Vacutainer® RST Tubes (5.0ml) ‐ BD Vacutainer® SST Tubes (3.5ml, 5.0ml) ‐ BD Vacutainer® Fluoride Tubes (Glucose Tubes) (2.0ml, 4.0ml, 6.0ml) ‐ BD Vacutainer® Serum Blood Collection Tubes (4.0ml, 6.0ml) ‐ BD Vacutainer® Lithium

Blood Collection Tube with Vacuum

7483‐R&I 29.05.2019

Rs. 5,000

06‐P(6A)DD(MD)

31‐05‐2019

Heparin Blood Collection Tubes (4.0ml, 6.0ml, 10ml) ‐ BD Vacutainer® Sodium Heparin Blood Collection Tubes (4.0ml, 6.0ml, 10ml) ‐ BD Vacutainer® Erythrocyte Sedimentation Rate Tube (1.8ml, 2.4ml, 5ml) ‐ BD Vacutainer® ACD Tube (6.0ml, 8.5ml) ‐ BD Vacutainer® CPT Tubes (4.0ml, 8.0ml) ‐ BD Vacutainer® PPT Plasma Preparation Tube (5.0ml) ‐ BD Vacutainer® Standard Yellow Holder ‐ BD Vacutainer® Luer Adaptor (Blood Collection Tube with Vacuum) (Codes not mentioned in Form 6‐A) Class A Shelf Life : Not mentioned clearly

2 M/s. Future Scientific, FS House, Opposite Street No. 4, Main Road Shaheen Town, Gangal West, Post Office, Fazaia Colony, Rawalpindi. ELI‐00209

Legal Manufacturer: M/s. D‐tek s.a. Parc Initialis Rue rene Descartes, 19 BE‐7000 Mons BELGIUM. FSC Belgium Issued on 06.02.2019

Blue Diver Instrument DrDOT Scanner Dr DOt Software LIC4 Class A Shelf Life : Not mentioned

Blue Diver Instrument DrDOT Scanner Dr DOt Software LIC4

3036‐R&I 09.04.2019

(2/2)

Rs. 5,000

13‐P(6A)‐DD(MD) 24‐04‐2019

3 M/s. Imtiaz Brothers Suite, 7B, 2nd Floor Abrar Business center 25‐Main Wahat Road Lahore. ELI‐00133

Legal Manufacturer: M/S Genoss Cp., Ltd located at 1st Floor, Gyeonnggi R&DB Center, 105 Gwanggyo‐ro, Yeongtong‐gu, Suwon‐si, Gyeonggi‐do Korea. FSC Koera. Date of issue Valid till 18.12.2019

GENOSS (Inflator Inflation Device (GBI‐30). Not mentioned Class‐A Shelf Life: 5 years

The GENOSS inflator is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

15038‐R&I 20.08.2019

(2/2) Rs 5,000

29‐P(A)‐DD(MD)

23.8‐2019

4 M/s. HAJI S. AMEER IN AND SONS 305‐A Upper Mall Lahore ELI‐00059

Legal Manufacturer: UNICOS Co, Ltd 282‐30, Munji‐ro, Yuseonji, Gu Deajeon,Korea FSC Korea. Date of issue 19th May,2019

ULM‐.800 Auto Lens Meter Not mentioned Class‐A

Auto Lens Meter 14570‐R&I 08.08.2019

(2/3) Rs 5,000

32‐P‐DD(MD)

26.8‐2019

Shelf Life: 7 years

5 M/s Alliance Medical 12‐B, 1st Floor, Agro Flats, Sherman, Lahore. .ELI‐00147

Legal Manufacturer: Genoss Co. Ltd. 1F, Gyeonggi R&DB Center, 226, 2F, GSBC, 105, Gwanggyo‐ro, Yeongtong‐gu, Suwon‐si, Gyeonggi‐do, Korea. FSC: Korea Date of issue 2.08.2017

(GENOSS Inflator Set.)

(Catherter Balloon)

CODES AS PER FSC:

GI30V‐BA1, GI30V‐BA2, GI30V‐BB1, GI30V‐BB2, GI30‐BA1, GI30‐BA2, GI30‐BB1, GI30‐BB2, GI30V‐SA1, GI30V‐SA2, GI30V‐SB1, GI30V‐SB2, GI30V‐S, GI30‐SA1, GI30‐SA2, GI30‐SB1, GI30‐SB2, GI40V‐BA1, GI40V‐BA2, GI40V‐BB1, GI40V‐BB2, GI40‐BA1, GI40‐BA2, GI40‐BB1, GI40‐BB2, GI40V‐SA1, GI40V‐SA2, GI40V‐SB1, GI40‐SA1, GI40‐SA2, GI40‐SB1, GI40‐SB2, GBI‐B30, GBI‐B30S, GBI‐B30V, GBI‐B30VS, GBI‐B40, GBI‐B40S, GBI‐B40V, GBI‐B40VS.

Class A

Shelf Life 3 years

The Genoss Inflators are designed to be used to inflate/deflate balloon catheters during angioplasty procedures as well as to monitor pressure within the balloon.

Note: applied on F‐7(A)

20252‐R&I 10.10.2019 Rs. 5,000

49‐P‐DD(MD) 10.10.2019

Check it

Part file of (GENOSS Inflator Set.), Catherter Balloon)

49‐P‐DD(MD) 10.10.2019

AD ‐2019

6 M/s Alliance Medical 12‐B, 1st Floor, Agro Flats, Shadman, Lahore. ELI‐00147

Legal Manufacturer:

Aries Srl, Via XXV Luglio 43 – 41037, Mirandola, Modena, Italy

Manufacturer Site: Millennium Utility Srl, via Gheorge Doiia 68, 43550 Sighetu Marmatiei Romania. FSC: Italy Date of issue 7.6.2017

(ARIES Three Stop Extension Line (Pressure Extension Line).

(Extension Line)

Codes:

IN022155, IN022160, IN022162, IN022165, IN022170, IN022155, IN026004, IN026005, IN026010, IN026012, IN026022, IN026025, IN026030, IN026035.

Class A

Shelf Life 5 years

The pressure monitoring line is intended to be used in fluid management and pressure monitoring applications.

Note: applied on F‐7 (A)

20252‐R&I 10.10.2019 Rs. 5,000

50‐P‐DD (MD)

10.10.2019

7 M/s Vantage Technologies House No. 251, Street 11‐B, Phase ‐1 Ghouri Town, Islamabad, ELI‐00219

Legal Manufacturer: IDL Biotech AB (Publ) Karlsbodavagen39, SE‐168 67 Bromma Sweden. Manufacturing Site: Karlsbodavagen 39, SE‐168 67Bromma, Sweden. FSC: Sweden Valid till 25.05.2022

((Tubex TF)

Rapid Typhoid Detection Kit

Code: 10‐201

Class A

Shelf Life : 18 months

Rapid Typhoid Detection Kit

19306‐R&I 01.10.2019 Rs. 5,000

51‐P‐DD (MD)

10.10.2019

8 M/s. Cardiac Care, Legal Manufacturer bO2 ugie Boussignac Guide for endotracheal 21127 R&I 18.10.19

848‐C Shadman‐I, Lahore.

ELI‐00070

VYGON

5 RUE Adeline‐95440 Ecouen‐France

FSC: France

Date of Issue 12.10.2016

(Guide for endotracheal tube)

Code: 557601/02/03

Class A

Shelf Life : 5 years

tube) Rs. 5,000 52‐P‐DD(MD) 18.10.2019

AD‐IV‐2019 15.06.2020

9 M/s Seico Scientific 104, Muhammadia plaza Gordon College Road, Rwp ELI: 00205

Legal Manufacturer TECAN Schweiz AG Seestrasse 10 CH‐8708 Mannedorf Switzerland "Distribute by Ortho Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF 35 5PZ United Kingdom

FSC:‐UK

Valid till: 03.11.2021

(Ortho Vision) Analyzer Code: 6904579 Class: A Self‐life Nil

ORTHO VISION® Analyzer is an instrument designed to automate in vitro immunohematology testing of human blood utilizing the Ortho BioVue® System cassette technology. ORTHOVISION® Analyzer automates test processing functions including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation, and data management requirements using cassettes and digital image processing. ORTHO VISION® Analyzer can be

22348 R&I 30.10.19

(1/7) Rs. 5,000

55‐P‐DD(MD) 30.10.2019


Legal Manufacturer TECAN Schweiz AG Seestrasse 10 CH‐8708 Mannedorf Switzerland "Distribute by Ortho Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF 35 5PZ United Kingdom

FSC:‐UK

Ortho vision

(Max)

Code:6904578 Class A

Self‐life Nil

ORTHO VISION® Max Analyzer is an instrument designed to automate in vitro immunohematology testing of human blood utilizing the Ortho BioVue® System cassette technology. ORTHO VISION® Max Analyzer automates test processing functions including liquid pipetting,

22348 R&I 30.10.19

(2/7) Rs. 5,000

56‐P‐DD(MD) 30.10.2019

Valid till: 03.11.2021 cassette and liquid handling, incubation, centrifugation, reaction grading and interpretation, and data management requirements using cassettes and digital image processing. ORTHO VISION® Max Analyzer can be used as a standalone instrument or interfaced to the customer's Laboratory Information System (LIS).


Legal Manufacturer

NPA de Mexico S.de R.L de CV Sor Juana Ines de la Cruz #20150 Interior 5, Cd Industrial Tijuana Baja California, Mexico 22444

Distribute by

Ortho Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF 35 5PZ United Kingdom FSC: UK Valid till: 13.11.2023

Vitros 5600 Immunodiagnostic Code:6802413 Software Code:6802864 Class A Self‐life Nil

For in vitro diagnostic use only. The VITROS 5600 Integrated System is intended for use in thein vitro quantitative, semi‐quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents

22348 R&I 30.10.19

(3/7) Rs. 5,000

57‐P‐DD(MD) 30.10.2019


Legal Manufacturer

NPA de Mexico S.de R.L de CV Sor Juana Ines de la Cruz #20150 Interior 5, Cd Industrial Tijuana Baja California, Mexico 22444

Distribute by

Ortho Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF 35 5PZ United Kingdom

Vitros 3600 Immunodiagnostic

Code:682783 Class A

Self‐life Nil

For in vitro diagnostic use only. The VITROS 3600 Immunodiagnostic System is intended for use in the in vitro quantitative, semi‐quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

22348 R&I 30.10.19

(4/7) Rs. 5,000

58‐P‐DD(MD) 30.10.2019

FSC: UK



Legal Manufacture PLEXUS CORP 2400 Millbrook Drive Buffalo Grove, IL 60089 USADistribute by Ortho Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF 35 5PZ, UK FSC: UK Valid till: 03.11.2023

Ortho Workstation

Code:6904629 Class A

Self‐life Nil

The ORTHO™ Workstation is intended to support the in vitro immunohematology testing of human blood through the incubation and centrifugation of BioVue® cassettes

22348 R&I 30.10.19

(5/7) Rs. 5,000

59‐P‐DD(MD) 30.10.2019

AD‐VII‐2019

15.06.2020 14 M/s Seico Scientific

104, Muhammadia plaza Gordon College Road, Rwp ELI: 00205

Legal Manufacture PLEXUS CORP 2400 Millbrook Drive Buffalo Grove, IL 60089 USA Distribute by Ortho Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF 35 5PZ, UK

FSC: UK


Vitros ECIQ Immunodiagnostic System

Code:1922814

Class A

Self‐life Nil

For In Vitro Diagnostic use only. The VITROS® ECi/ECiQ Immunodiagnostic System perform random access, batch, and STAT immunodiagnostic assays on human fluid specimens. The system uses chemiluminescence detection technology to provide accurate and reliable results for heterogeneous assays. All reactions for a single quantitative, semi‐quantitative, and qualitative measurement take place within a coated well.

22348 R&I 30.10.19

(6/7) Rs. 5,000

60‐P‐DD(MD) 30.10.2019

15 M/s. Future Scientific, FS House, Opposite Street No. 4, Main Road Shaheen Town, Gangal West, Post Office, Fazaia Colony, Rawalpindi.

ELI‐00209

Legal Manufacturer: Nano‐Ditech Corporation 259 Prospect Plains Rd, BLdg K Cranbury, USA FSC: USA Valid till 02.6.2024

Nano Checker ™ 710 Immunoassay Analyzer Code: NDT710 Class A Shelf Life: …..

Immunoassay Analyzer

22981‐R&I 07.11.19

(4/5) 5,000/‐

63.‐P‐DD(MD) 08.11.19

16 M/s. Asto Life Sciences. (Pvt) Plaza No. 1, Orchard 1 Block, Paragon City Barki Road Lahore Cantt. . ELI‐00103

Legal Manufacturer:

Becton, Dickinson and Company

BD, 1 Becton Drive, Franklin Lakes, NJ 07417 USA

Manufacturer Site:

BD Diagnostics, Preanalytical Systems 1575 Airport Rd. Sumter, SC 29151 Phone: 803‐469‐8010

FDA (US)

Date of issue September 11, 2019 valid till September 10, 2021

BD Vacutainer® Standard Yellow Holder


GMDN Code 36188

HS Code 9018:3990

Class A

Shelf Life: No Shelf Life Assigned

BD VACUTAINER® Standard Size Yellow Holder is intended to be coupled with a BD VACUTAINER® PrecisionGlide™ Blood Collection Needle in order to facilitate the insertion of the needle into the patient’s vein and to help guide the evacuated blood collection tube onto the non‐patient (NP) end of the needle during the blood collection process. BD VACUTAINER® Standard Size Yellow Holder is also used to attach and hold a VACUTAINER® Brand venous access device (i.e., needle, blood collection set) during venipuncture and to connect these devices to VACUTAINER® Brand Tube

26172‐R&I 05.12.19

(1/19) 5,000/‐

64.‐P‐DD(MD) 20.12.19


Legal Manufacturer:

Becton Dickinson and Company Belliver Industrial Estate, Belliver Way Roborough, Plymouth PL6 7BP, United Kingdom

Manufacturer Site:

Becton, Dickinson and Company (BD) 150 South First Avenue Broken Bow NE 68822 USA

FSC Refer to Annex A

Date of issue 31/05/2018

valid till : onwards

BD Vacutainer® One Use Holder


GMDN Code 36188

HS Code 9018:3990

Class A

Shelf Life

NA (Long Shelf life – Plastic)

The BD Vacutainer® One Use Holder is intended to be used in conjunction with the BD

Vacutainer® range of blood collection needles, blood collection sets and luer adapter in order to facilitate

the insertion of the needle into the patient’s vein and to help guide the evacuated blood collection tube

onto the non‐patient (NP) end of the needle during the blood collection process.

The intended users of this device are trained phlebotomists or other suitably trained healthcare

professionals.

26172‐R&I 05.12.19

(2/19) 5,000/‐

65.‐P‐DD(MD) 20.12.19


Legal Manufacturer:



Manufacturer Site:

Becton, Dickinson and Company Address: 1575 Airport Road Sumter, SC 29153

BD Vacutainer® SST Tubes (3.5ml, 5.0ml)

Blood Collection Tube with Vacuum GMDN Code 41128 HS Code 9018:3990

Class A Shelf Life 3.5ml: 12

BD Vacutainer® Serum Tubes are sterile, single‐use, evacuated blood collection tubes that provide a means of collecting, transporting, separating, and processing blood in a closed tube. BD Vacutainer® SST™ Tubes contain a separator gel, and the tube walls are coated with a clot activator, a surfactant, a binder and a closure lubricant.

26172‐R&I 05.12.19

(3/19) 5,000/‐

66.‐P‐DD(MD) 20.12.19

FDA (US) Refer to Annex A

Date of issue September 11, 2019

valid till September 10, 2021

months 5.0ml: 12 months


Legal Manufacturer:

Becton, Dickinson and Company Belliver Industrial Estate, Belliver Way Roborough, Plymouth PL67BP United Kingdom.

Manufacturer Site:

Becton, Dickinson and Company Belliver Industrial Estate, Belliver Way Roborough, Plymouth PL67BP United Kingdom




BD Vacutainer® Plus EDTA Tube (10 ml)


GMDN Code 43865

HS Code 9018:3990

Class A

Shelf Life 15 Months

The BD Vacutainer® Plus EDTA Tube is a sterile, single use, in vitro diagnostic medical device specifically intended to be used for the collection, primary containment and preservation of venous blood specimens derived from the human body and when required, the subsequent separation and preservation of EDTA plasma samples for the purposes of in vitro diagnostic examination. This device is intended to be used by trained phlebotomists or other suitably trained healthcare professionals

26172‐R&I .12.19 (4/19) 5,000/‐

67.‐P‐DD(MD) 20.12.19

20 M/s. Asto Life Sciences. (Pvt) Plaza No. 1, Orchard 1 Block, Paragon City Barki Road Lahore Cantt. .

Legal Manufacturer:


M f t Sit

BD Vacutainer® Plus Plasma Separator Tubes (PST™ II) – 3ML

GMDN Code 46054

HS Code 9018:3990

BD Vacutainer® Plus Plasma Separator Tubes (PST™ II) are sterile (interior), single‐use, in vitro diagnostic medical devices, containing a premeasured amount of vacuum, the anticoagulant lithi h i d l t

26172‐R&I 05.12.19

(5/19) 5,000/‐

68.‐P‐DD(MD) 20.12.19


Legal Manufacturer:



Manufacturer Site:

Becton, Dickinson and Company 150 South First Avenue Broken Bow, Nebraska 68822



BD Vacutainer® Lithium Heparin Blood Collection Tubes (4.0ml, 6.0ml, 10ml)

Blood Collection Tubes with Vacuum

GMDN Code 47592

HS Code 9018:3990

Class A

Shelf Life 4.0ml: 16 months

6.0ml: 17 months 10ml: 24 months

BD Vacutainer® Heparin Tubes are sterile, single‐use, in vitro diagnostic medical devices. They are intended to be used for the collection, primary containment and preservation of venous blood specimens derived from the human body and, when required, the subsequent separation and preservation of a plasma sample for the purposes of in vitro diagnostic examination

26172‐R&I

05.12.19 (6/19) 5,000/‐

69.‐P‐DD(MD) 20.12.19


Legal Manufacturer:

Becton, Dickinson and Company BD, 1 Becton Drive, Franklin Lakes, NJ 07417 USA . Manufacturer Site: Becton, Dickinson and Company 150 South First Avenue Broken Bow, Nebraska 68822

BD Vacutainer® Sodium Heparin Blood Collection Tubes (4.0ml, 6.0ml, 10ml)

GMDN Code 47592 HS Code 9018:3990

Class A

BD Vacutainer® Heparin Tubes are sterile, single‐use, in vitro diagnostic medical devices. They are intended to be used for the collection, primary containment and preservation of venous blood specimens derived

26172‐R&I 05.12.19

(7/19) 5,000/‐

70.‐P‐DD(MD) 20.12.19

FDA (US) Refer to Annex A Date of issue September 11, 2019 valid till September 10, 2021

Shelf Life = 4.0ml: 16 months

6.0ml: 17 months 10ml: 24 months

from the human body and, when required, the subsequent separation and preservation of a plasma sample for the purposes of in vitro diagnostic examination




Manufacturer Site:


FDA (US)


BD Vacutainer® Plus Citrate Tubes (1.8ml, 2.7ml, 4.5ml)

Blood Collection Tubes with Vacuum

GMDN Code 42585

HS Code 9018:3990

Class A

Shelf Life: 1.8ml = 13 Months

2.7ml = 13 Months

4.5ml = 13 Months

BD Vacutainer Tubes containing sodium citrate tubes are sterile, single use, evacuated blood collection tubes containing sodium citrate that provide a means of collecting, transporting, separating, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

26172‐R&I 05.12.19

(8/19) 5,000/‐

71.‐P‐DD(MD) 20.12.19


Legal Manufacturer:

Becton, Dickinson and Company BD, 1 Becton Drive, Franklin Lakes, NJ 07417 USA . Manufacturer Site: Becton, Dickinson and Company 1575 Airport Road Sumter, SC 29153 USA

FDA (US) Date of issue September

BD Vacutainer® Luer Adaptor

Blood Collection Tubes with Vacuum GMDN Code 36188 HS Code 9018:3990

Class A Shelf Life = 62 months

The Vacutainer® Luer Adapter is a sterile, non‐invasive device used to connect venous access devices such as needles, blood collection sets, and infusion sets to blood collection tubes. They are also used in connection with non‐needle devices for collection of blood from

26172‐R&I 05.12.19

(9/19) 5,000/‐

72.‐P‐DD(MD) 20.12.19

11, 2019 valid till September 10, 2021

catheters. 1


Legal Manufacturer:



Manufacturer Site:

Becton, Dickinson and Company 1575 Airport Road Sumter, South Carolina 29153 USA




BD Vacutainer® Serum Blood Collection Tubes (4.0ml, 6.0ml) Blood Collection Tubes with Vacuum

GMDN Code 42386

HS Code 9018:3990

Class A

Shelf Life: 4.0ml = 18 Months

6.0ml = 18 Months

BD Vacutainer® Serum Blood Collection Tubes are sterile, single‐use, evacuated blood collection tubes that provide a means of collecting, transporting, separating, and processing blood in a closed tube.

26172‐R&I 05.12.19 (10/19) 5,000/‐

73.‐P‐DD(MD) 20.12.19


Legal Manufacturer



.

Manufacturer Site:

Becton, Dickinson and Company 150 South First Avenue Broken Bow, NE 68822 USA (Annex J)


BD Vacutainer® CPT™ Cell Preparation Tube Blood Collection Tubes with Vacuum

GMDN Code 42916

HS Code 9018:3990

Class A

Shelf Life: 4.0ml: 15 months

8.0ml: 13

BD Vacutainer® CPT Cell Preparation Tubes are single‐use, sterile in‐vitro diagnostic medical devices. They consist of a glass “test‐tube” containing a sodium citrate or sodium heparin anticoagulant and a cell separation medium, comprised of a polyester gel and a density gradient liquid. A predetermined vacuum is created inside the tube, which is sealed

26172‐R&I 05.12.19 (11/19) 5,000/‐

74.‐P‐DD(MD) 20.12.19


months

with a closure. The internal pressure of the tube determines the quantity of blood that will be drawn into the tube


Legal Manufacturer:

Becton, Dickinson and Company BD, 1 Becton Drive, Franklin Lakes, NJ 07417 USA . Manufacturer Site: Becton, Dickinson and Company 150 South First Avenue Broken Bow, NE 68822 USA FDA (US) Refer to Annex A Date of issue September 11, 2019 valid till September 10, 2021

BD Vacutainer® PPT Plasma Preparation Tube (5.0ml) Blood Collection Tubes with Vacuum

GMDN Code 46054 HS Code 9018:3990

Class A Shelf Life = 17 months

The Vacutainer® PPT™ Plasma Preparation Tube with EDTA anticoagulant and a gel barrier material are evacuated blood collection tubes which provide a means of collecting, processing and transporting blood in a closed plastic tube. When the Tube is used together with Vacutainer® needles and holders, it is a closed system for the collection of venous blood with the same indications identified here. Blood collected in a tube containing EDTA anticoagulant and gel barrier material can be primarily used to provide undiluted plasma for use in molecular diagnostic test methods; including but not limited to Polymerase Chain Reaction (PCR) and branched‐DNA (bDNA). The specimen may also be used

26172‐R&I 05.12.19 (12/19) 5,000/‐

75.‐P‐DD(MD) 20.12.19

for other testing that requires an undiluted plasma sample as determined by the laboratory


Legal Manufacturer:



.

Manufacturer Site:

Becton, Dickinson and Company 150 South First Avenue Broken Bow, NE 68822 USA




BD Vacutainer® Fluoride Tubes (Glucose Tubes) (2.0ml, 4.0ml, 6.0ml)

Blood Collection Tubes with Vacuum)

GMDN Code 47591

HS Code 9018:3990

Class A

Shelf Life 2.0ml = 12 Months

4.0ml = 12 Months

6.0ml = 12 Months

BD Vacutainer® Blood Collection Tubes containing Sodium Fluoride and Potassium Oxalate are intended to provide a means of collecting, transporting, separating, and processing blood in a closed tube. Glucose tubes are used for glucose determinations. The intended users of this device are trained phlebotomists or other suitably trained professionals

26172‐R&I 05.12.19 (13/19) 5,000/‐

76.‐P‐DD(MD) 20.12.19

29 M/s. Asto Life Sciences. (Pvt) Plaza No. 1, Orchard 1

Legal Manufacturer:


BD Vacutainer® RST Tubes 5.0ml

BD Vacutainer® RST Tubes are intended to provide a means of collecting,

26172‐R&I 05.12.19 (14/19)

Block, Paragon City Barki Road Lahore Cantt. . ELI‐00103


Manufacturer Site: Tokuyama Sekisui Co., Ltd. Kaisei‐cho, Shunan City Yamaguchi, 746‐0006 Japan Phone number: 81‐834‐63‐0188 FDA (US) Refer to Annex A




GMDN Code 42368

HS Code 9018:3990

Class A

Shelf Life = 12 months

transporting, separating, and processing blood in a closed tube. Blood collected in BD Vacutainer® RST Tubes clots rapidly (within 5 minutes) and are therefore suitable for stat testing in clinical laboratories, such as routine chemistry assays using patient serum.

5,000/‐ 77.‐P‐DD(MD)

20.12.19


Legal Manufacturer:


Manufacturer Site:

Becton, Dickinson and Company Belliver Industrial Estate, Belliver Way Rodborough, Plymouth PL67BP United Kingdo




BD Vacutainer® Plus Plasma Separator Tubes (PST™ II) – 3ML


GMDN Code 46054

HS Code 9018:3990

Class A

Shelf Life = 18 Months

BD Vacutainer® Plus Plasma Separator Tubes (PST™ II) are sterile (interior), single‐use, in vitro diagnostic medical devices, containing a premeasured amount of vacuum, the anticoagulant lithium heparin and a gel to separate plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. The device is comprised of a plastic (polyethyleneterephthalate) tube containing a Hemogard™ stopper (butyl rubber), and a plastic (low density polyethylene) BD Hemogard™ cap (according

26172‐R&I 05.12.19 (15/19) 5,000/‐

78.‐P‐DD(MD) 20.12.19

to size). The interior of the Plus Heparin Plasma Separator Tube (PST™ II) contains a PS510 Gel (Silicon dioxide, acrylic resin & additives) and is spray coated with a heparin anticoagulant.

31 M/s. Asto Life

Sciences. (Pvt) Plaza No. 1, Orchard 1 Block, Paragon City Barki Road Lahore Cantt. . ELI‐00103

Legal Manufacturer:



Manufacture Site:





BD Vacutainer® Erythrocyte Sedimentation Rate Tube (1.8ml, 2.4ml, 5ml) Blood Collection Tubes with Vacuum GMDN Code 42585 HS Code 9018:3990

Class A Shelf Life 1.6ml & 2.4ml: 18 months

5.0ml: 12 months

BD Vacutainer® Glass ESR Blood Collection Tube use a controlled vacuum to draw a specific volume of venous blood into the sterile interior of the tube via a venous acquisition device. The tube is intended to be placed inside a tube holder or an adapter of the acquisition device. Once the vein has been penetrated (using either a standard blood collection needle or a blood collection set) the tube is pushed fully into the holder or adapter so that the non‐patient (NP) end of the needle pierces the rubber septum of the stopper in the tube. The pressure differential causes the venous blood to flow into the tube. Once a tube has drawn the appropriate amount of blood, it is disengaged from the holder and inverted the recommended number of times (8‐10 times (8‐10x)).

26172‐R&I 05.12.19 (16/19) 5,000/‐

79.‐P‐DD(MD) 20.12.19

Additional evacuated tubes can be inserted to collect successive blood specimens. When blood collection is complete, the needle is withdrawn from the arm and discarded safely. The filled tubes are dispatched to the appropriate analytical laboratory


Legal Manufacturer:



.Manufacturer Site:




BD Vacutainer® ACD Tube (6.0ml, 8.5ml) Blood Collection Tubes with Vacuum) GMDN Code 42583 HS Code 9018:3990

Class A

Shelf Life 6.0ml = 25 Months

8.5ml = 25 Months

BD Vacutainer® ACD Solution Blood Collection Tubes are sterile (interior), single‐use, in vitro diagnostic medical devices, containing a pre‐measured amount of vacuum and the anticoagulant acid citrate dextrose solution. They are specifically intended to be used for the collection, transport and preservation of venous blood specimens derived from the human body. The device is comprised of a glass (soda glass) tube containing a standard stopper (butyl rubber), and where applicable a plastic (low‐density polyethylene) Hemogard™ closure. The interior of the BD Vacutainer® ACD Solution Blood Collection Tubes holds ACD solution (Tri‐

26172‐R&I 05.12.19 (17/19) 5,000/‐

80.‐P‐DD(MD) 20.12.19

sodium citrate, citric acid, dextrose and potassium sorbate (quantities vary).

33 M/s. Future Scientific, FS House, Opposite Street No. 4, Main Road Shaheen Town, Gangal West, Post Office, Fazaia Colony, Rawalpindi.

ELI‐00209

Legal Manufacturer: Nano‐Ditech Corporation 259 Prospect Plains Rd, BLdg K Cranbury, USA FSC: USA Valid till 02.6.2024

Fluoro Checker ™ TRF Immunoassay Analyzer Code: NDT101 Class A Shelf Life: …..

Immunoassay Analyzer

22981‐R&I 07.11.19

(5/5) 5,000/‐

83.‐P‐DD(MD) 20.12.19

34 OPTISURG 17/c‐1, Valancia Town, Lahore Pakistan

(ELI‐00305

Legal Manufacturer: MORIA SA (Private limited) MORIA SA (Private limited) 15 Rue George Besse 92160 Antony‐France FSC: France Date of issue 9th November,2018

(EVOLUTION 2‐3‐3E TUBINGx10) Evolution 2‐3‐3E Tubing of Microkeratome system Ref No. 19138

Clas: A

Shelf Life: 59 months

The aspiration tubing is indicated to maintain the suction ring during LASIK surgeries.

24666‐R&I 22.11.19 5,000/‐

84‐P‐DD(MD) 22.11.19

35 M/s Chemical House

6‐C Sikander Malhi Road Gulberg II Lahore, Pakistan

ELI: 00156

Legal Manufacturer Bio –Red 3 Boulevard Raymond Poincare, 92430 Marnes‐la‐Coquette France FSC: France Date of issue: 15.03.2019

Evolis Twin Plus Cat # 93501 Class: A

Evolis Twin Plus

25338‐R&I 28.11.19 5,000/‐

85‐P‐DD(MD) 29.11.19

36 M/s.MEDICAMP INTERNATIONAL, Office no 1, First Floor, Raja Naseer Plaza, New Abadi, Morgah, Rawalpindi, Pakistan

(ELI‐00200)

Legal Manufacturer:

M/s. NURTEKS TEKSTIL ve MEDIKAL SANAYI DIS TIC. A.S.,KÖŞKLÜ Çeşme Mah.Yeni bağdat Cad. No.124 Gebze / KOCAELI‐TURKEY

Manufacturer Site:

FSC : TURKEY Date of issue: 5th Dec.2017

(Broche)

Reinforced Surgical Gown

Code: LARGE‐EXTRA LARGE

EXTRA EXTRA LARGE‐MEDIUM

Class: A

Shelf Life : 5 years

Intended for use by medical personnel in the hospital wards, reception and also by visitors. It is perfect protection against contamination.

28855‐R&I 01.01.2020

5,000/‐ 86‐P‐DD(MD) 01.01.2020

37 M/s Intek Corporation,Office # 30, Al Amin Plaza, the Mall, Rawalpindi

ELI: 00034

Lepu Medical Technology (Beijing) Co., Ltd, No. 37 Chaoqian Road, Changping District, Beijing, China 102200

FSC China

RAYBAND RADIAL ARTERY COMPRESSION TOURNIQUETS

(Radial Artery Compression Device)

Size Variants:

LPYP20S YPR15S LPYP20 YPR15 LPYP20L YPR15L LPYP20XL YPR15XL LPYP15S YPR20S LPYP15 YPR20 LPYP15L YPR20L LPYP15XL YPR20XL

Radial Artery Compression Tourniquet is principally used for the compression hemostasis after percutaneous arterial interventional operations,

29527‐R&I 08.01.2020

5,000/‐

87‐P‐DD(MD) 10.01.2020

38 M/s Global Marketing Services, 111, Hali Road Westridge 1, Rawalpindi, Pakistan

ELI‐00109

Legal Manufacturer: Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 USA

Physical Manufacture: COPAN Italia S.p.A. Via Perotti, 10 25125 Brescia – ITALY FSC: Italy Date of issue 20.10.2018

Xpert Collection Devices (Sample collection kits/devices) SWAB/A‐50, SWAB/B‐100, SWAB/F‐100, URINE/A‐50 Class: A Shelf Life: 36 month

Designed to collect, preserve, and transport specimens from patients.

30613‐A‐R&I 16.01.2020

5000/‐ 88‐P‐DD(MD) 17.01.2020


ELI‐00109

Bio Fire Diagnostics, LLC

515 Colorow Drive, Salt Lake City, Utah 84108,USA

FSC: USA

Date of issue: 13.08.2021

Film Array® Instrument Systems

Film Array 2.0 (FLM2‐ASY‐0001) Film Array Torch System (HTFA‐ASY‐0104) Film Array Torch Module (HTFA‐SUB‐0103) Film Array Torch Duplex (HTFA‐ASY‐0102) Class‐ A Shelf Life:

An automated in vitro diagnostic (IVD) device designed for use with Film Array panels. Film Array is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis.

30613‐A‐R&I 16.01.2020

5,000/‐ 89‐P‐DD(MD) 17.01.2020


ELI‐00109



FSC: USA




An automated in vitro diagnostic (IVD) device designed for use with Film Array panels. Film Array is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The software automatically determines the results and

30613‐A‐R&I 16.01.2020

5,000/‐ 89‐P‐DD(MD) 17.01.2020


ELI‐00109



FSC: USA




An automated in vitro diagnostic (IVD) device designed for use with Film Array panels. Film Array is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis.

30613‐A‐R&I 16.01.2020

5,000/‐ 89‐P‐DD(MD) 17.01.2020


ELI‐00109

Legal Manufacturer:

Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 USA Telephone: +1 408.541.4191 www.cepheid.com

Physical Manufacture: Sanmina Corporation 2700 North First Street San Jose 95134 USA Phone: (408) 964‐3500 Website: www.sanmina.com FSC: USA

GeneXpert® Instrument Systems

(GX‐I, GX‐II, GX‐IV, GX‐XVI, GX‐I R2, GX‐II R2, GX‐IV R2, GX‐XVI R2, GeneXpert Infinity‐48 System, GeneXpert Infinity‐48s System, Gene Xpert Infinity‐80 System XPERTCHECK‐CE‐5 Class: A Shelf Life:

The GeneXpert® Instrument Systems automate and integrate sample preparation, nucleic acid amplification, and detection of the target sequence in simple or complex samples using real‐time Polymerase Chain Reaction (PCR). The system is suited for in vitro diagnostic applications that require hands‐off processing of patient samples (specimens) and provides both summarized and detailed test results data in tabular and graphic formats. The Gene Xpert® Instrument Systems are designed exclusively for the use of Cepheid Xpert® assay applications. It allows a lab healthcare

30613‐A‐R&I 16.01.2020

5,000/‐ 90‐P‐DD(MD) 17.01.2020

43 M/s. Freesia Enterprises

Address: First Floor,104 Dawn Plaza, Bank Road, Saddar, Rawalpindi

ELI:00201 18‐10‐2018

Legal Manufacturer:

Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia

FSC: Malaysia


Comfit powered latex examination Gloves non‐sterile Size: XS: CI0000‐01 Size S: CI001‐01 Size M: CI002‐01 Size L: C1003‐01 Size XL: CI004‐01 Class –A Shelf Life: 3 years

COMFIT NR Latex Examination Gloves (powered and non‐sterile). The examination glove is intended for medical purposes such as for conducting medical examination, diagnostic and therapeutic procedures that is worn on the examiner’s hand to prevent contamination between the examiner and patient.

30912‐R&I 20.01.2020

(11/11) 5,000/‐

91‐P‐DD(MD) 20.01.2020

44 M/s Global Marketing Services 111, Hali Road Westridge 1, Rawalpindi,Pakistan

ELI‐00109

Legal Manufacturer:

STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, USA Manufacturing Site: STERIS Corporation, 9325 Pinecone Dr, Mentor, OH 44060, USA

FSC: U.S.FOOD &DRUG

Valid till: 30th October,2020

Celerity 20 HP Biological Indicator System

Biological Indicator

CELERITY 20 HP BI (BOX OF 25 BIS) (LCB044) CELERITY HP INCUBATOR (LCB046 Class: A Shelf Life

Celerity 20 HP Biological Indicator (BI) is intended for use in routine monitoring, and qualification of low temperature / hydrogen peroxide sterilization process. The incubator is designed to detect the presence or absence of fluorescent signal upon incubation of the Celerity HP BIs.

30646‐R&I 17.01.2020

5,000/‐

92‐P‐DD(MD) 20.01.2020

45 M/s Global Marketing Services 111, Hali Road Westridge 1, Rawalpindi, ,Pakistan

ELI‐00109

Legal Manufacturer STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, USA Manufacturing Site: STERIS Corporation, ST‐Louis Facility, 7501 Page Avenue, St‐Louis, Missouri, 63133, USA US Endoscopy, 5976 Heisley Road, Mento, Ohio, 44060, USA

FSC: USA]

Date of Issue: 21.10.2019

REVITAL‐OX Brushes & Cleaning Chemistry

2D60QH, 2D62QH, 2D63QH, 2D64QH, 2D75QV, 2D76QH, 2D77QH, 2D78QV, 2D83QH, 2D91QX, 2D92QH, 2D99AW Class: A Shelf Life:

CAT. NO. SHELF LIFE 2D77QH n/a 2D91QX 12

Months 2D92QH n/a 2D76QH n/a 2D75QV n/a

Instrument cleaning chemistries & brushes for cleaning & pre‐cleaning of endoscopes & surgical instruments

30646‐R&I 17.01.2020

5,000/‐

93‐P‐DD(MD) 20.01.2020


ELI‐00109

Legal Manufacturer: STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, USA Manufacturing Site: STERIS Corporation, 9325 Pinecone Dr, Mentor, OH 44060, USA FSC: U.S.FOOD &FOOD&DRUG Valid till 30TH October,2020

Verify Self‐Contained Biological Indicator

(Self‐Contained Biological Indicator) Code: LCB030, LCB031, LCB022 Class: A Shelf Life: Verify Assert Incubator: a/a Verify Assert SCBI: 10 Months f h

Verify SCBIs are intended for use in routine monitoring, load release, product testing, and qualification of steam sterilization process. The incubator is designed to detect the presence or absence of fluorescent signal upon incubation of the VERIFY Assert SCBIs.

30646‐R&I 17.01.2020

5,000/‐

94‐P‐DD(MD) 20.01.2020


ELI‐00109

Legal Manufacturer: STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, USA Manufacturing Site: STERIS Corporation, 9325 Pinecone Dr, Mentor, OH 44060, USA FSC: U.S.FOOD &FOOD&DRUG Valid till 30TH October,2020

Prolystica Cleaning Chemistry

1C3272PE, 1C32T4PE, 1C32T6PE, 1C3208WR, 1C33T1PE, 1C33T4PE, 1C3308WR, 1C3372PE, 1C33T6PE, 1C34T4PE, 1C34T6PE, 1C3472PE, 1C3408WR, 1C45T6WR, 1C45T4PE, 1C45AW Class: A Shelf Life:24 months

Instrument cleaning chemistries to clean, restore and protect surgical instruments and medical devices

30646‐R&I 17.01.2020

5,000/‐

95‐P‐DD(MD) 20.01.2020


ELI‐00109

Legal Manufacturer:

Albert Browne Ltd., Chancery House, Rayns Way,Watermead Business Park, Syston, Leicester, LE7 1PF,United Kingdom

FSC: United Kingdom


Albert Browne Indicators

Sterility Assurance Products BROWNE Spiral Load Check (No Counter and No Indicators) ‐ AB123 VH202 Process Indicator BOX/200 ‐ 2501AB Indicator Steam Multivariable (BOX OF 240) ‐ 2551AB Porous & Hollow Steam Penetration Test ‐ AB101 Class:A Shelf Life

Product Identifier

Shelf Life

AB123 400 cycles

2501AB 15 Months

2551AB 24 Months

AB101

24 months or 400 cycles

Albert Browne Indicators are sterility assurance products intended for use inside individual packs, trays or pouches or as Process Challenge Device to provide assurance of the sterility activity.

30646‐R&I 17.01.2020

5,000/‐

96‐P‐DD(MD) 20.01.2020


ELI‐00109

Legal Manufacturer: Albert Browne Ltd., Chancery House, Rayns Way, Watermead Business Park, Syston, Leicester, LE7 1PF, United Kingdom

FSC: United Kingdom


STF Load Check Indicator

Test Soil

1. 2315AB ‐ STF Load Check

Indicator (Pack of 100) 2. 2316AB ‐ STF Load Check

Holder Class:A

Shelf Life:

STF Load Check Indicator: 12 Months

The Browne STF Load Check Indicator and Holder have been carefully designed to perform in an equivalent manner to ‘test soils’ by providing a realistic multiple challenge for the washer‐disinfector machine. Containing two sources of protein, lipids and polysaccharides, the Browne STF Load Check Indicator mimics the cleaning efficacy soil tests for surgical instruments described in ISO/TS 15883‐5. The Browne STF Load Check Indicator contains no blood products.

30646‐R&I 17.01.2020

5,000/‐

97‐P‐DD(MD) 20.01.2020


ELI‐00109

Legal Manufacturer:

Albert Browne Ltd., Chancery House, Rayns Way, Watermead Business Park, Syston, Leicester, LE7 1PF, United Kingdom

TST Indicator

(Time, Steam & Temperature sensitive indicators

1. 2341AB ‐ TST Control

Indicator 2. 2352AB ‐ TST Bowie Dick

Test (20 Packs) Class:A Shelf Life: 36 Months

Sterility assurance product for process completion indicator & steam penetration tests for large porous load sterilizer

30646‐R&I 17.01.2020

5,000/‐

98‐P‐DD(MD) 20.01.2020


ELI‐00109

Legal Manufacturer: STERIS Corporation, ST‐Louis Facility, 7501 Page Avenue, St‐Louis, Missouri, 63133, USA Manufacturing Site: STERIS Corporation, ST‐Louis Facility, 7501 Page Avenue, St‐Louis, Missouri, 63133, USA FSC: UK Date of issue: 07.10.2018

Pre‐Klenz Instrument Transport Gel

(Instrument Transport Gel)

150377 ‐ PRE‐KLENZ (12 X 22 OZ‐CASE) Class: A Shelf Life: 36 months

PRE‐KLENZ™ Instrument Transport Gel combines a surfactant‐based gel with corrosion inhibitors so that cleaning can be initiated at point of use, moisture can be maintained during transport and the instrument surface is protected. By utilizing a gel technology, PRE‐KLENZ™ Instrument Transport Gel clings to instrument surfaces and no significant weight is added to instruments during transport. PRE‐KLENZ™ Instrument Transport Gel reduces exposure risk to employees who process surgical instruments by reducing sloshing and splashing associated with liquid presoaks.

30612‐R&I 16.01.2020

5,000/‐

99‐P‐DD(MD) 20.01.2020


ELI‐00109

Legal Manufacturer: Albert Browne Ltd., Chancery House, Rayns Way, Watermead Business Park, Syston, Leicester, LE7 1PF, United Kingdom FSC: UK Date of issue: 21.10.2019

Westfield Pouches

Sterilization rolls

NWFL05200, NWFL10100, NWFL10200, NWFL125200, NWFL15200, NWFL20200, NWFL25200, NWFL30200, NWFL35200, NWFL40200, NWTY0570, NWTY1070, NWTY1570, NWTY2070, NWTY2570, NWTY3070, NWTY3570, NWTY4070, NWTY5070, NWTY7570 Class: A Shelf life:5 years

Westfield Pouches are sterilization paper rolls (Flat / Tyvek) suitable for packaging extra‐long products or creating individual pouches of special length. These single‐use sterilization packaging are an economical and convenient way to packageinstruments, swabs and other items for sterilization. Tyvek® is a unique material used in sterile barrier systems. Tyvek® is known for its outstanding strength, durability, and tear resistance. As well as industrial use for EO and Gamma Sterilization, Tyvek® is also used for VHP™ (Vaporised Hydrogen Peroxide)

30612‐R&I 16.01.2020

5,000/‐

100‐P‐DD(MD) 20.01.2020


ELI‐00109

Legal Manufacturer: STERIS Corporation, ST‐Louis Facility, 7501 Page Avenue, St‐Louis, Missouri, 63133, USA Manufacturing Site: STERIS Corporation, ST‐Louis Facility, 7501 Page Avenue, St‐Louis, Missouri, 63133, USA FSC: UK

(Hinge Free Instrument Lubricant)

(Instrument Lubricant)

1. 103172PE ‐ HINGE‐FREE

(20 L Bucket) 2. 1031T4PE ‐ HINGE‐FREE

(2 x 5 Liters) 3. 103108 ‐ HINGE‐FREE (4 X

1 GAL Case) 4. 103105 ‐ HINGE‐FREE (5

GAL Bucket) Cl A

Hinge‐Free is intended to be used after every cleaning and before sterilization to extend the life of the surgical instrument. Used in both manual and automated washer cycles, Hinge‐Free lubricates hinges and protects all types of stainless‐steel surgical instruments

30612‐R&I 16.01.2020

5,000/‐

101‐P‐DD(MD) 20.01.2020

54 M/s Kaumedex

E‐144/2, New Super Town Link‐2 Defence Road, Lahore.

ELI‐00162

Legal Manufacturer Supermax Gloves Manufacturing SDN BHD Lot 38, PUTRA Industrial Park, Bukit Rahman PURTA 47000 SUNGAI BULOH SELANGOR 47000 Malaysia. FSC: Malaysia Valid till: 20.06.2020

High‐Max Non‐Sterile Latex Examination Gloves, Lightly powdered. LP‐XS (70‐79mm PALM WIDTH) LP‐S (80‐89mm PALM WIDTH) LP‐S (90‐99mm PALM WIDTH LP‐L (100‐109mm PALM WIDTH LP‐XL (110‐119mm PALM WIDTH

Non‐Sterile Latex Examination Gloves, Lightly powdered.

30546‐R&I 16.01.2020

5,000/‐ 102‐P‐DD(MD)

20.01.2020

55 M/s Global Health Care

Midway commercial Plaza No.20, Back Side Prism Arcade‐2, Bahria Town Phase 7 Rawalpindi.

ELI‐ 00086

Legal Manufacturer Boditech Med Inc. Site :1:43 Geodudanji 1‐gil, Dongnae‐myeon, Chungcheon‐si, Gang‐won‐do 24398 Republic of Korea Site: 2: 14, Geodudanji 1‐giL, Dongnae‐myeon, Chungcheon‐si, Gang won do 24398, Republic of Korea. FSC: Korea Date of issue: 19.10.2018

Ichroma ™ Reader 1 Ichroma(RM) II (Analyser, Fluorescence immunoassay automatic Class: A

Ichroma™ Reader is a florescence scanning instrument to be used in conjuction with various ichroma ™ Immunoassay Tests which are based on antigen‐antibody reaction and fluorescence technology.

Ichroma™ II is a flurorescence and Europium nanoparticle scanning instrument to be used in conjunction with various ichroma™ Immunoassary Tests which

b d ti

30645‐R&I 17.01.2020

5,000/‐ 103‐P‐DD(MD)

20.01.2020

56 M/s ASTO Life Science Pvt. Ltd .Plaza No 1, Orchard 1 Block, Paragon City, Barki Road Lahore Cantt, Lahore

ELI: 00103

Legal Manufacturer: Becton, Dickinson and Company BD, 1 Becton Drive, Franklin Lakes, NJ 07417 USA . Manufacturer Site: BD Caribe LTD. Rd 31, Km 24.3 Juncos, Puerto Rico 00777 USA FDA (US)

BD Microtainer® MAP (Micro Blood Collection Tube) Code ……58144… Class ……A……………… Shelf Life 16 Months

The BD Microtainer® MAP Microtube for Automated Process with K2EDTA is used to collect, anticoagulate, transport and store skin puncture blood specimens for the measurement of hematology parameters using automated processes

30914‐R&I 17.01.2020

(1/6) 5,000/‐

104‐P‐DD(MD) 20.01.2020 AD‐IV‐2020 15.06.2020


ELI: 00103

Legal Manufacturer: Becton, Dickinson and Company BD, 1 Becton Drive, Franklin Lakes, NJ 07417 USA . Manufacturer Site: BD Caribe LTD. Rd 31, Km 24.3 Juncos, Puerto Rico 00777 USA FDA (US) Date of issue September 11, 2019 valid till September 10, 2021

BD Microtainer® SST‐AMBER Micro Blood Collection Tube) Code ……58144 Class ……A… Shelf Life: 15 Months

BD Microtainer® Blood Collection Tubes are single‐use, non‐sterile In Vitro Diagnostic blood collection tubes, which provide a means for the collection, transport, and processing of skin puncture blood. The tubes are applicable to the general population, but are particularly used on infants, small children, geriatric, and critical care patients from whom venous blood specimens are particularly difficult to obtain. The BD Microtainer® Blood Collection Tubes contain a separator gel.

BD Microtainer® Blood Collection Tubes are used to collect, transport and store skin puncture blood specimens for hematology

30914‐R&I 17.01.2020

(2/6) 5,000/‐

105‐P‐DD(MD) 20.01.2020


ELI: 00103


BD Microtainer® SST Micro Blood Collection Tube Code ………58144……………… Class ……A……………… Shelf Life: 15 months


BD Microtainer® Blood Collection Tubes are used to collect, transport and store skin puncture blood specimens for hematology tests, or for tests utilizing serum or heparinized plasma. The intended users of BD Microtainer® blood collection tubes are trained phlebotomists or other suitably trained healthcare professionals

30914‐R&I 17.01.2020

(3/6) 5,000/‐

106‐P‐DD(MD) 20.01.2020 AD‐IV‐2020 15.06.2020


ELI: 00103


BD Microtainer® SST Micro Blood Collection Tube Code ………58144……………… Class ……A……………… Shelf Life: 15 months


BD Microtainer® Blood Collection Tubes are used to collect, transport and store skin puncture blood specimens for hematology tests, or for tests utilizing serum or heparinized plasma. The intended users of BD Microtainer® blood collection tubes are trained phlebotomists or other suitably trained healthcare professionals

30914‐R&I 17.01.2020

(3/6) 5,000/‐

106‐P‐DD(MD) 20.01.2020


ELI: 00103

Legal Manufacturer: Becton Dickinson and Company Belliver Industrial Estate, Belliver Way Roborough, Plymouth PL6 7BP, United Kingdom Manufacturer Site: Becton, Dickinson and Company Belliver Industrial Estate, Belliver Way Rodborough, Plymouth PL67BP United Kingdom

BD Vacutainer® Precision Glide™ Multiple Sample Needle (21G x 1.5” & 22G x 1.5”) Micro Blood Collection Tube Code …… 35209 …………… Class ……B……………… Shelf Life : 5 Years

BD Vacutainer® PrecisionGlideTM needles can be used for multiple tube samples. BD Vacutainer® PrecisionGlideTM needles have an advanced low angle bevel design and

are coated with silicone, a low friction lubricant, ensuring very gentle and smooth vein entry. Individual laser quality control maintains the highest quality levels. BD

30914‐R&I 17.01.2020

(4/6) 5,000/‐

107‐P‐DD(MD) 20.01.2020


ELI: 00103

Legal Manufacturer: Becton, Dickinson and Company BD, 1 Becton Drive, Franklin Lakes, NJ 07417 USA . Manufacturer Site: BD Caribe LTD. Rd 31, Km 24.3 Juncos Puerto Rico 00777

BD Microtainer® TUBE EXTENDOR Micro Blood Collection Tube Code …… 46237………………… Class ……A……………… Shelf Life N/A

BD Microtainer® Brand Tube Extenders are adaptors. They simply increase the exterior dimensions of small blood collection tubes so that they are more compatible with equipment (for example centrifuges and test tube holders) designed for standard size tubes BD

30914‐R&I 17.01.2020

(5/6) 5,000/‐

108‐P‐DD(MD) 20.01.2020


ELI: 00103


BD Microtainer® EDTA Micro Blood Collection Tube Code……58144………………… Class ……A……………… Shelf Life: 16 Months

BD Microtainer ® EDTA

Tubes are single‐use, non‐sterile In Vitro Diagnostic blood collection tubes, which provide a means for the collection, transport, and processing of skin puncture blood. The tubes are applicable to the general population, but are particularly used on infants, small children, geriatric, and critical care patients from whom venous blood specimens are particularly difficult to obtain. The BD Microtainer® Blood Collection Tubes contain anticoagulant.

BD Microtainer® Blood Collection Tubes are used to collect, transport and store skin puncture blood specimens for hematology

30914‐R&I 17.01.2020

(6/6) 5,000/‐

109‐P‐DD(MD) 20.01.2020

2020

63 M/s Global Marketing Services 111, Hali Road Westridge 1, Rawalpindi, Pakistan

ELI‐00109

Legal Manufacturer: Bio‐Optica Milano S.p.A. Via San Faustino 58 ‐ 20134 Milano FSC: Italy Date of issue: 28.06.2019

Bio Optica ( Slide Staining Sets)

10‐10, 10‐20, 10‐30, 10‐33, 10‐42

Class‐A

Shelf Life N/a

Slide staining system for histological and cytological staining

32117‐R&I 30.01.2020

5,000/‐

110‐P‐DD(MD) 30.01.2020


ELI‐00109


Bio Optica Microscopic Slides & Cover galsses 09‐1000TB, 09‐1000MB, 09‐1000, 09‐1010, 09‐1020, 09‐1030, 09‐1040, 09‐1050, 09‐2000, 09‐3000, 09‐2040, 09‐2050, 09‐2060 Class‐A h lf f

Microscopic Slides & Covergalsses

32119‐R&I 30.01.2020

5,000/‐

111‐P‐DD(MD) 30.01.2020


ELI‐00109


Bio Optica Embedding Molds

07‐BM15155, 07‐BM24245, 07‐BM30245, 07‐BM37245, 07‐BM775, 07‐MBM6, 07‐7010, 07‐MP1515, 07‐MP2424, 07‐MP3024, 07‐MP3724, 07‐MP7070

CLASS‐A

Molds for the embedding of histological samples

32118‐R&I 30.01.2020

5,000/‐

112‐P‐DD(MD) 30.01.2020


ELI‐00109

Legal Manufacturer: Bio‐Optica Milano S.p.A. Via San Faustino 58 ‐ 20134 Milano FSC: Italy Date of issue: 28.06.2019.

Bio Optica Histology Cassettes

07‐7100, 07‐7110, 07‐7120, 07‐7130, 07‐7140, 07‐7150, 07‐7160, 07‐7180, 07‐8100, 07‐8110, 07‐8120, 07‐8130, 07‐8140, 07‐8150, 07‐8160, 07‐7350, 07‐086‐74195, 07‐7200, 07‐7210, 07‐7220, 07‐7230, 07‐7250, 07‐7260, 07‐7280, 07‐8200, 07‐8210, 07‐8220, 07‐8230, 07‐8250, 07‐8260, 07‐8280, 07‐7300, 07‐7000, 07‐9700, 07‐9710, 07‐9720, 07‐9730, 07‐9740, 07‐9750, 07‐9760

Cassettes for the embedding of histological / biopsy samples

32120‐R&I 30.01.2020

5,000/‐

113‐P‐DD(MD) 30.01.2020


ELI‐00109

Legal Manufacturer: Bio‐Optica Milano S.p.A. Via San Faustino 58 ‐ 20134 Milano FSC: Italy Date of issue: 28.06.2019.

Bio Optica Histology / Cytology Reagents

65‐30001S, 65‐30001F, 05‐01V3000P, 05‐01V250P, 05‐01V30P, 05‐01V60P, 05‐01V5000P, 05‐01V500P, 05‐01P05, 05‐01V1000P, 05‐01V125P, 05‐01V15P, 05‐K01009, 05‐K01009R, 05‐01005Q, 05‐K01004R, 05‐K01004, 05‐01004F, 05‐01020Q, 30‐50100, 05‐M05009, 05‐M05014, 05‐B11001, 30‐30118LY, 04‐021002, 04‐045801, 05‐B04002, 34‐P105/10, 34‐P105/25, 04‐165812, 04‐166802, 04‐160802, 04‐161802, 04‐163802, 04‐169812, 05‐B05011, 30‐30121LY, 04‐140808, 05‐B10006, 30‐30125LY, 05‐B07014, 04‐001802, 05‐M01023, 30‐30111, 05‐07012/L, 04‐040805, 06‐1782Q, 05‐000‐030, 05‐015‐240, 05‐015‐030‐1, 05‐015‐030, 05‐014‐240, 05‐014‐030‐1, 05‐014‐030, 05‐016‐240, 05‐016‐030‐1, 05‐016‐030, 05‐018‐240, 05‐018‐030‐1, 05‐018‐030, 05‐020‐240, 05‐020‐030‐1, 05‐020‐030, 05‐019‐240, 05‐019‐030‐1, 05‐019‐030, 05‐017‐240, 05‐017‐030‐1, 05‐017‐030, 05‐BMHM100, 05‐BMHM508, 08‐7910, 08‐7910/20, 08‐7920K, 08‐7920, 08‐7915, 05‐9803S, 05‐03009Q, 05‐M03009, 05‐X200, 05‐M26005, 05‐26003/L, 05‐B26003, 05‐M26003, 05‐01008Q, 05‐M01008, 05‐B14002, 04‐100807, 05‐06012/L, 05‐M06012, 05‐01013E, 15‐M103, 04‐180809, 04‐210822, 34‐P158/25, 34‐P158/10, 05‐B16001, 05‐9802, 08‐SPRAY, 34‐P176/100, 05‐01C50L, 05‐01C50P, 05‐01C51P, 30‐30115LY, 04‐220822, 05‐03003E, 06‐10075Q, 06‐10075F, 65‐30013S, 65‐30013F, 06‐10070Q, 06‐10070F, 65‐30008S, 65‐30008F, 06‐10077Q, 06‐10077F, 65‐30009S, 65‐30009F, 04‐140805, 05‐M01024, 15‐M820, 05‐03004Q, 05‐M03004, 15‐M840, 05‐10020/L, 05‐M10020, 05‐11007/L, 34‐P132/100, 34‐P132/25, 05‐10002/L, 05‐10002E, 05‐M10002, 05‐10003/L, 05‐10003E, 05‐M10003, 05‐12055, 04‐120802, 30‐30120, 05‐01007Q, 05‐K01007, 04‐060802, 04‐121872, 04‐045872, 05‐B10005, 05‐B04004, 04‐090803, 05‐12005/L, 05‐12005E, 05‐M12005, 05‐06013/L, 05‐06014/L, 05‐06014E, 05‐M06014, 05‐06015/L, 05‐06015E, 05‐M06015, 30‐30110, 04‐040802, 04‐100802, 04‐100803, 04‐100804, 04‐044822, 04‐043823, 04‐043823W, 05‐06004/L, 05‐06004E, 05‐M06004, 34‐P129/100, 34‐P129/25, 05‐01030E, 04‐150805, 05‐M05001, 08‐1730/A270, 08‐1730/A30, 05‐12021/L, 05‐12020/L, 05‐9801B, 05‐9801, 05‐B14004, 05‐M10008, 34‐P172/100, 34‐P172/25, 05‐M05016, 05‐05015/L, 05‐M05015, 05‐B18001,

Reagents for the preparation of cyto‐histological samples. Please refer to Grouping Sheet

32121‐R&I 30.01.2020

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5,000/‐ 114‐P‐DD(MD)

30.01.2020

68 Part of 2 of Bio Optica /Cytology Reagents Cassettes AD‐III

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114‐P‐DD(MD)

30.01.2020 72 Part of 6 of Bio Optica /Cytology Reagents Cassettes

AD‐III

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30.01.2020 73 Part of 7 of Bio Optica /Cytology Reagents Cassettes

AD‐III

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114‐P‐DD(MD) 30.01.2020

76 M/s Hashir Surgical Services Office No.16, Street 1, F‐2, Phase 6, Hayatabad, Peshawar. Office No.05, 2nd Floor, Syed’s Tower, University Road, Peshawar. House No.2, Street No.1, Gulshan Colony, GT

Legal Manufacturer Head Office:No.1 Guoxiang Road ,Wujin Economic Development Zone, Changzhou,Jiangsu , China Factory:Jiangsu nanfang medical co.,ltd, No.1 Guoxiang Road ,Wujin Economic Development Zone, Changzhou,Jiangsu , FSC: China

MEDISOFT Wound Dressing PU (Wound Dressing)

5cmx7cm‐6cmx8cm‐6cmx9cm 7cmx12cm‐8cmx10cm‐10cmx12cm 8cmx15cm‐9cmx10cm‐9cmx15cm 9cmx20cm‐9cmx25cm‐9cmx30cm 10cmx10cm‐10cmx12cm‐10cmx15cm

MEDISOFT is a non‐woven, lightweight, breathable Wound Dressing; uniformly coated with a hypoallergenic and sensitive under pressure acrylic adhesive on one side. Can be safely used as island dressing on hypersensitive parts of the body, e.g.: infant’s skin, skin allergies, facial wounds Secure fixation

31686‐R&I 27.01.2020

5,000/‐

115‐P‐DD(MD) 30.01.2020

77 M/s. Tech Zone

Ground Floor Weal House, 8 Faiz Road, Old Muslim Town Lahore.

(ELI‐00040)

Legal Manufacturer:

M/s. PIKDARE Manufacturer Site:

VIA SALDARINI CATELLI 10, 22070 CASNATE CON BERNATE COMO – ITALY

FSC: ITALY


valid till 14.05.2021

SOFFIX MED (PIC SOLUTION

Post Op Dressing

Codes:02022670300000, 02022670200000, 02022671300000 02022671200000, 02022672300000, 02022672200000 02022673300000 02022673200000 02022674300000 02022674200000 02022675300000 02022675200000

A POST OP DRESSING IS AN ADHESIVE DRESSING WITH STERILE PAD APPLIED TO A WOUND TO PROMOTE HEALING AND PROTECT THE WOUND FROM FURTHER HARM

31092‐R&I 21.01.2020

5,000/‐ 116‐P‐DD(MD)

30.01.2020

78 M/s. Tech Zone

Ground Floor Weal House, 8 Faiz Road, Old Muslim Town Lahore.

(ELI‐00040)

Legal Manufacturer: M/s. PIKDARE Manufacturer Site:

VIA SALDARINI CATELLI 10, 22070 CASNATE CON BERNATE COMO – ITALY

FSC: ITALY


valid till 14.05.2021

AQUABLOC (PIC SOLUTION )

Water Proof Post Op Dressing

Codes:02026008000000 02026009000000 02026010000000 02026011000000 02026012000000 02026013000000 02026014000000

Class: A

Shelf Life: 05 years

A WATER PROOF POST OP DRESSING IS AN ADHESIVE DRESSING WITH STERILE PAD APPLIED TO A WOUND TO PROMOTE HEALING AND PROTECT THE WOUND FROM FURTHER HARM

31092‐R&I 21.01.2020

5,000/‐ 117‐P‐DD(MD)

30.01.2020

79 M/s. Chemical House

6‐C Sikander Malhi Road, Canal Park, Gulberg II Lahore, Pakistan

(ELI‐00156

Legal Manufacturer:

M/S Bio‐Rad Laboratories Inc. USA

M/s. Manufacturer Site:

4000 Alfred Nobel Drive Hercules , CA , 94547 USA

FSC from: US Food and Drug Administration

Date of issue: Feb. 13, 2019

Date of Expiry: Feb 12, 2021

Product names

* D‐100 Hemoglobin Testing System

Code (12008984, 12006848)

Class A

Shelf Life: N/A

Uses the principle of HPLC for determination of HbA1c

31684‐R&I 27.01.2020

5,000/‐ 118‐P‐DD(MD)

30.01.2020

80 M/s. Chemical House

6‐C Sikander Malhi Road, Canal Park, Gulberg II Lahore, Pakistan

(ELI‐00156

Legal Manufacturer:

M/S Bio‐Rad Laboratories Inc. USA

M/s. Manufacturer Site:

4000 Alfred Nobel Drive Hercules , CA , 94547 USA

FSC from: US Food and Drug Administration

Date of issue: Feb. 13, 2019

Date of Expiry: F

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