Catalog Number

3K-01-16003C

Brand Name

GL GoodLife Blood Glucose Test Strip AC (50ct in foil)

Version/Model Number

AC11-Foil

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 13, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113307,K113307

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

120225fd-044a-4df5-86dc-dce5d42d0ab3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 08, 2016

Package DI Number

00389154000556

Quantity per Package

100

Contains DI Package

00389154000075

Package Discontinue Date

March 13, 2017

Package Status

Not in Commercial Distribution

Package Type

Foil