Catalog Number

3S-01-16003E

Brand Name

GL GoodLife Blood Glucose Test Strip

Version/Model Number

AC-11 AC302 (vial)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 09, 2016

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113307,K113307

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

c42b7dcf-89e2-4592-baba-49c88b25536d

Public Version Date

December 27, 2019

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

03891450006004

Quantity per Package

400

Contains DI Package

00389154000594

Package Discontinue Date

December 09, 2016

Package Status

Not in Commercial Distribution

Package Type

-