Catalog Number

-

Brand Name

TRUEbalance

Version/Model Number

TRUEbalance 10 Blood Glucose Test Strips

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

Yes

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

9e51a482-efdb-410a-851a-13a2ee1fec06

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

00021292003142

Quantity per Package

1

Contains DI Package

00021292007942

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box