Catalog Number

-

Brand Name

TRUE METRIX

Version/Model Number

TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 25 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

c556653e-e3d2-4083-ae03-9b0a1c6839d0

Public Version Date

March 10, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

00021292006174

Quantity per Package

1

Contains DI Package

00021292007829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box