Catalog Number

RE4203-01

Brand Name

TRUE METRIX

Version/Model Number

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

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

45368f34-109f-440f-b29b-b9752a59a29b

Public Version Date

July 13, 2022

Public Version Number

1

DI Record Publish Date

July 05, 2022

Package DI Number

10041260016025

Quantity per Package

12

Contains DI Package

00041260016028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case