Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-5125A3

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

45a788ea-c903-4c75-90a5-5da4347a4409

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 21, 2018

Package DI Number

40612479228762

Quantity per Package

4

Contains DI Package

20612479228751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case