Catalog Number

21-6608A

Brand Name

CARDINAL HEALTH

Version/Model Number

21-6608A

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

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Public Device Record Key

4ba6226e-fb33-4655-8c84-149902e9ea6e

Public Version Date

August 07, 2020

Public Version Number

4

DI Record Publish Date

September 08, 2017

Package DI Number

50887488783336

Quantity per Package

12

Contains DI Package

10887488783338

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE