Catalog Number

-

Brand Name

McKesson

Version/Model Number

121-PNS

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JIL

Product Code Name

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Public Device Record Key

e4976c7f-96d6-4a31-a173-5296d8ecf6e7

Public Version Date

October 31, 2022

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

40612479197204

Quantity per Package

50

Contains DI Package

20612479197194

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case