Catalog Number

-

Brand Name

McKesson

Version/Model Number

MCK03-4490

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

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

b27dc91a-3027-4a3c-a7ce-84fd88ed9d52

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 18, 2020

Package DI Number

20612479258444

Quantity per Package

25

Contains DI Package

10612479258430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box