Catalog Number

A4007-81

Brand Name

TRUEtrack

Version/Model Number

TRUEtrack Blood Glucose Monitoring System

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

-

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

713daa34-8e6a-481f-b0d2-c29a5b59a068

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

December 22, 2016

Package DI Number

10050428264703

Quantity per Package

12

Contains DI Package

00050428264706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE