Catalog Number

H4H01-81

Brand Name

TRUEbalance

Version/Model Number

TRUEbalance BLOOD GLUCOSE MONITORING 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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090495,K090495,K090495

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

b6a1ac3a-367b-4f39-9e2e-d9c2cbdf97a8

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

20212920031352

Quantity per Package

40

Contains DI Package

00021292003135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case