Catalog Number

-

Brand Name

TRUEtrack

Version/Model Number

TRUEtrack 25 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

K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657,K032657

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

4c452f75-6a89-42b2-aa51-12e0d6bcee80

Public Version Date

November 22, 2021

Public Version Number

8

DI Record Publish Date

September 20, 2016

Package DI Number

00311917104881

Quantity per Package

1

Contains DI Package

00021292008888

Package Discontinue Date

July 31, 2017

Package Status

Not in Commercial Distribution

Package Type

Box