Catalog Number

RE4068P-01

Brand Name

TRUE METRIX PRO

Version/Model Number

Professional Monitoring Blood Glucose Meter TRUE METRIX PRO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2018

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

4c1117aa-fdb7-4565-8a79-9dbf503caf36

Public Version Date

June 12, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10607415261094

Quantity per Package

6

Contains DI Package

00607415261097

Package Discontinue Date

May 11, 2018

Package Status

Not in Commercial Distribution

Package Type

Case