Catalog Number

CA20625

Brand Name

CARDINAL HEALTH

Version/Model Number

CA20625

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)

Yes

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

103ce52a-3fd6-4785-b713-4a6c0460a1de

Public Version Date

February 04, 2019

Public Version Number

1

DI Record Publish Date

January 04, 2019

Package DI Number

50885380168770

Quantity per Package

50

Contains DI Package

10885380168772

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE