Catalog Number

CA2300A

Brand Name

CARDINAL HEALTH

Version/Model Number

CA2300A

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

77cc03e4-a69d-4148-b0b2-c9084b1794b3

Public Version Date

January 31, 2019

Public Version Number

2

DI Record Publish Date

December 18, 2018

Package DI Number

50885380168725

Quantity per Package

50

Contains DI Package

10885380168727

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE