TRUEtrack - LEADER TRUEtrack Blood Glucose Monitoring System - TRIVIDIA HEALTH, INC.

Duns Number:151810868

Device Description: LEADER TRUEtrack Blood Glucose Monitoring System

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More Product Details

Catalog Number

A4002-81

Brand Name

TRUEtrack

Version/Model Number

TRUEtrack Blood Glucose Monitoring System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2019

Issuing Agency

In GS1

Product Characteristics

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

K032657,K032657

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

387273a7-3d6d-4885-9ee9-40e0abe33987

Public Version Date

November 01, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

50096295111861

Quantity per Package

12

Contains DI Package

00096295111866

Package Discontinue Date

October 07, 2019

Package Status

Not in Commercial Distribution

Package Type

Case

"TRIVIDIA HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 22