Catalog Number

-

Brand Name

GE

Version/Model Number

GE100

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092052,K092052,K092052

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

b4bfb54c-9f7d-490e-bd2d-c55ef245c629

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 14, 2016

Package DI Number

20883489001201

Quantity per Package

50

Contains DI Package

00883489001207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton