Catalog Number

-

Brand Name

Mckesson

Version/Model Number

06-R5051-3

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"

Yes

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

-

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

16cd3fd2-8d08-4fc7-be7d-cd2472193c43

Public Version Date

September 09, 2020

Public Version Number

2

DI Record Publish Date

August 19, 2020

Package DI Number

20612479197378

Quantity per Package

1

Contains DI Package

10612479250458

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box