Catalog Number

CH3050-4

Brand Name

CARDINAL HEALTH

Version/Model Number

CH3050-4

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

JXA

Product Code Name

KIT, SCREENING, URINE

Public Device Record Key

2947e227-10bd-47a7-9b74-263e7c499f39

Public Version Date

May 07, 2019

Public Version Number

1

DI Record Publish Date

April 29, 2019

Package DI Number

50885380068520

Quantity per Package

10

Contains DI Package

20885380068529

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE