Catalog Number

RE4054-01

Brand Name

TRUE METRIX

Version/Model Number

sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

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

-

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

36c10570-9450-43bc-a66a-6402de9c2637

Public Version Date

November 12, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10010939719444

Quantity per Package

12

Contains DI Package

00010939719447

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case