Catalog Number

-

Brand Name

TRUE METRIX

Version/Model Number

TRUE METRIX Self Monitoring 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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

b320c4be-8f70-48fd-aa9c-ea709971de1b

Public Version Date

January 28, 2021

Public Version Number

3

DI Record Publish Date

February 01, 2018

Package DI Number

10681131240168

Quantity per Package

24

Contains DI Package

00681131240161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE