Catalog Number

-

Brand Name

McKesson

Version/Model Number

5059

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092052,K092052,K092052,K092052

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

ce5009d5-4379-46ee-b693-9935781f28e9

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

20612479197156

Quantity per Package

2

Contains DI Package

10612479212784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box