Catalog Number

-

Brand Name

McKesson

Version/Model Number

121-MAC

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JFY

Product Code Name

Enzymatic Method, Creatinine

Public Device Record Key

ed65c95a-ea49-4446-9435-ba3fb2c78f62

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

20612479197507

Quantity per Package

1

Contains DI Package

10612479197494

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box