Catalog Number

-

Brand Name

Gmate® Origin Blood Glucose Monitoring System

Version/Model Number

PG-310

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

K151658

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

453f9cfb-2aa0-4116-b803-a0d09b94addd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-