Catalog Number

-

Brand Name

GlucoTrack SMART Blood Glucose Monitoring System

Version/Model Number

GT-101

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

K131230

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

15e1032a-887a-4d11-85e1-e00d63fb59a5

Public Version Date

September 17, 2018

Public Version Number

1

DI Record Publish Date

August 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-