Catalog Number

3L-10-810037

Brand Name

GL GoodLife Blood Glucose Test Strip-Foil For Cloudia

Version/Model Number

IG STRIP FOIL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 28, 2018

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

K131173,K131173

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

7c0da9e8-c47a-47dc-b3fd-18529a3f26e4

Public Version Date

December 28, 2018

Public Version Number

4

DI Record Publish Date

November 14, 2017

Package DI Number

00389154000495

Quantity per Package

210

Contains DI Package

00389154000266

Package Discontinue Date

December 28, 2018

Package Status

Not in Commercial Distribution

Package Type

Foil