Catalog Number

-

Brand Name

Gmate® Blood Glucose Test Strips

Version/Model Number

PS-004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K150299,K151658,K141656,K113636,K113636,K141656,K150299,K151658,K141656,K150299,K151658,K113636

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

a2c057f8-4f6e-4702-a9c5-9e15de5636ab

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 06, 2017

Package DI Number

08809301161012

Quantity per Package

2

Contains DI Package

08809301161029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-