product specification bd 3ml · 2019. 11. 29. · iso 7886-1 / iso 7886-2 iso 80369-7 medical...

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PRODUCT INFORMATION PRODUCT DESCRIPTION Three piece BD single use syringe packs PRODUCT FEATURES Materials Barrel and plunger – polypropylene Gasket – latex-free, medical grade rubber Lubricant – medical grade silicone oil (<0.25 mg/cm²) Connection type Luer-Lock (central) Applicable standards ISO 7886-1 / ISO 7886-2 ISO 80369-7 Medical device classification Class I (sterile) MANUFACTURING Becton Dickinson & Company 1 Becton Drive Franklin Lakes NJ 07417 USA PACKAGING Four layer laminate Easy tear notch Alcohol and VHP compatible STERILISATION DETAILS Gamma irradiation min. 25kGy Complies with applicable parts of ISO 11137 series QUALITY ASSURANCE Manufactured under a BS EN ISO 13485:2016 quality management system SHELF LIFE 3 years from date of manufacture STORAGE CONDITIONS Store in a dry, well ventilated area and protect from direct sunlight and heat sources SYRINGE MULTIPACKS BD 3ML ISSUE 1 | DATE 05/07/2018 | PAGE 1 OF 2 PRODUCT SPECIFICATION STERILE PACKS

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Page 1: PRODUCT SPECIFICATION BD 3ML · 2019. 11. 29. · ISO 7886-1 / ISO 7886-2 ISO 80369-7 Medical device classification Class I (sterile) MANUFACTURING Becton Dickinson & Company 1 Becton

PRODUCT INFORMATION

PRODUCT DESCRIPTIONThree piece BD single use syringe packs

PRODUCT FEATURESMaterialsBarrel and plunger – polypropyleneGasket – latex-free, medical grade rubberLubricant – medical grade silicone oil (<0.25 mg/cm²)

Connection type Luer-Lock (central)

Applicable standardsISO 7886-1 / ISO 7886-2ISO 80369-7

Medical device classificationClass I (sterile)

MANUFACTURINGBecton Dickinson & Company 1 Becton Drive Franklin Lakes NJ 07417 USA

PACKAGINGFour layer laminate Easy tear notch Alcohol and VHP compatible

STERILISATION DETAILSGamma irradiation min. 25kGy Complies with applicable parts of ISO 11137 series

QUALITY ASSURANCEManufactured under a BS EN ISO 13485:2016 quality management system

SHELF LIFE3 years from date of manufacture

STORAGE CONDITIONSStore in a dry, well ventilated area and protect from direct sunlight and heat sources

SYRINGE MULTIPACKSBD 3ML

ISSUE 1 | DATE 05/07/2018 | PAGE 1 OF 2

PRODUCT SPECIFICATIONSTERILE PACKS

Page 2: PRODUCT SPECIFICATION BD 3ML · 2019. 11. 29. · ISO 7886-1 / ISO 7886-2 ISO 80369-7 Medical device classification Class I (sterile) MANUFACTURING Becton Dickinson & Company 1 Becton

TECHNICAL INFORMATION

Compatible with gamma irradiationBSE/TSE – considered not to present any risk*Phthalate freeLatex freePVC freeSingle scale easy to read graduation

* raw materials may contain tallow-derived substances which have been produced under conditions which meet or exceed the requirements of EN 22442-1 and EMA 410/01 and are therefore considered not to present any risk in respect of TSE/BSE or other animal-borne diseases.

ORDERING/PACKING INFORMATION

Roman Bank | Skegness | Lincolnshire | PE25 1SQT. 01754 767377| E. [email protected] | W. www.micronclean.com

ISSUE 1 | DATE 05/07/2018 | PAGE 2 OF 2

Code Description Size Pack Qty Case Qty Case Dimensions Weight

03ML05CC 3ml luer lock syringe plus tip protector, 5 pack 3ml 5 100 0.80 KG280 x 170 x 200mm

03ML10CC 3ml luer lock syringe plus tip protector, 10 pack 3ml 10 100 0.55 KG280 x 170 x 200mm

03ML25CC 3ml luer lock syringe plus tip protector, 25 pack 3ml 25 250 1.00 KG280 x 170 x 200mm

03ML25CH 3ml luer lock syringe plus tip protector and cap, 25 pack 3ml 25 250 1.00 KG280 x 170 x 200 mm

03ML25SC 3ml luer lock syringe plus barcode and cap, sleeved, 25 x 12 pack 3ml 25 300 3.30 KG280 x 340 x 400mm

03ML50CC 3ml luer lock syringe plus tip protector, 50 pack 3ml 50 500 2.50 KG280 x 340 x 400mm