Catalog Number

CA7025A

Brand Name

CARDINAL HEALTH

Version/Model Number

CA7025A

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"

-

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

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Public Device Record Key

f35a49af-21ec-4aaa-a1bc-8a5bc008564b

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 21, 2018

Package DI Number

50885380168732

Quantity per Package

100

Contains DI Package

10885380168734

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE