u.s. food & drug - warmilu

U.S. FOOD & DRUG U.S. Food & Drug Adminstration 10903 New Hampshire Avenue Silver Spring. 1O 20993 ADM1 NISTR ATION www.fda.gov UGICALMEALTH CERER POR SAND Certificate No. 8085-3- -2018 CERTIFICATE TO FOREIGN GOVERNMENT In order to allow the importation of United States products into foreign countries, the U.S. Food and Drug Administration (FDA)certifies the following information concerning the product(s) to be exported listed below: Name of Product(s) Name of Manufacturer/Distributor, Address InstaWarmer Pack See Attached List (One Page) The product(s)described above (and the manufacturing/distribution site(s) which produces/distributes it) is subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act It is certified that the above device product(s) may be marketed in, and legally exported from, the United States of America at this time. While the manufacturing plant(s) in which the device product(s) is produced is subject to inspection, FDA does not routinely inspect manufacturing firms that only make Class 1 medical devices. However the firm has certified that it is currently operating in substantial compliance with current good manufacturing practice requirements for the device product(s) listed above. CAPT Sean M. Boyd, MPH, USPHS Deputy Director for Regulatory Affairs Office of Compliance Center for Devices and Radiological Health U.S. Food and Drug Administration, DHHS X This certificate is valid from March 22, 2018 to March 21, 2020

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U.S. FOOD & DRUG U.S. Food & Drug Adminstration

10903 New Hampshire Avenue

Silver Spring. 1O 20993 ADM1 NISTR ATION

www.fda.gov UGICALMEALTH CERER POR SAND

Certificate No. 8085-3- -2018

CERTIFICATE TO FOREIGN GOVERNMENT

In order to allow the importation of United States products into foreign countries, the U.S. Food and Drug

Administration (FDA)certifies the following information concerning the product(s) to be exported listed below:

Name of Product(s) Name of Manufacturer/Distributor, Address

InstaWarmer Pack See Attached List

(One Page)

The product(s)described above (and the manufacturing/distribution site(s) which produces/distributes it) is subject

to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act

It is certified that the above device product(s) may be marketed in, and legally exported from, the United States of

America at this time. While the manufacturing plant(s) in which the device product(s) is produced is subject to

inspection, FDA does not routinely inspect manufacturing firms that only make Class 1 medical devices. However

the firm has certified that it is currently operating in substantial compliance with current good manufacturing

practice requirements for the device product(s) listed above.

CAPT Sean M. Boyd, MPH, USPHS

Deputy Director for Regulatory Affairs

Office of Compliance

Center for Devices and Radiological Health

U.S. Food and Drug Administration, DHHS

This certificate is valid from March 22, 2018 to March 21, 2020

U.S. FOOD & DRUG U.S. Food &Drug Administration

10903 New Hampshire Avenue ADMIN ISTRAYI ON Silver Spring, MD 20993

www.fda gov

Certificate No. 8085-3-2018

Certificate to Foreign Government - Name of Manufacturer/Distributor Attachment Page 1 of 1

Name of Owner Operator tor

Warmilu

8186 Jackson Road, Suite C

Ann Arbor, MI USA 48103

Name of Manufacturer

WARMILU LLC

8186 JACKSON RD STE C

Ann Arbor, Ml USA 48103

Name of Distributor

WARMILU LLC

8186 JACKSON RD STE C

Ann Arbor, MI USA 48103

---END OF MANUFACTURER/DISTRIBUTOR LIST

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