Catalog Number

RE4081-03

Brand Name

TRUE METRIX

Version/Model Number

TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM

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

2324004f-75a7-44e3-b8c1-451a5b5d4c67

Public Version Date

August 16, 2021

Public Version Number

1

DI Record Publish Date

August 06, 2021

Package DI Number

10021292014794

Quantity per Package

12

Contains DI Package

00021292014797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE