Catalog Number

-

Brand Name

McKesson

Version/Model Number

121-120

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)

Yes

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

4f61c038-7f11-4b6f-a12a-05ca505f1438

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

July 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-