Catalog Number

RE4097-01

Brand Name

TRUE METRIX

Version/Model Number

TRUE METRIX self monitoring blood glucose meter

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 25, 2020

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)

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

f5cd3a71-9bc1-42bb-a907-c7a2970ecc0e

Public Version Date

March 10, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10725439988930

Quantity per Package

12

Contains DI Package

00725439988933

Package Discontinue Date

February 25, 2020

Package Status

Not in Commercial Distribution

Package Type

Case