Catalog Number

-

Brand Name

TRUEtrack

Version/Model Number

TRUEtrack 50 Blood Glucose Test Strips

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

-

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

5664dc0c-cc1a-41fd-ab5f-fcb7ca0f83e9

Public Version Date

May 09, 2022

Public Version Number

9

DI Record Publish Date

September 20, 2016

Package DI Number

00840986016776

Quantity per Package

1

Contains DI Package

00021292008642

Package Discontinue Date

September 22, 2016

Package Status

Not in Commercial Distribution

Package Type

Box