Catalog Number

A4H01-81

Brand Name

TRUEtrack

Version/Model Number

TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 04, 2019

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

-

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

K032657,K032657

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

529ff21c-cd97-42da-bf68-665ec982554b

Public Version Date

November 01, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

10021292001015

Quantity per Package

12

Contains DI Package

00021292001018

Package Discontinue Date

October 04, 2019

Package Status

Not in Commercial Distribution

Package Type

Case