Catalog Number

CHIP99CP42

Brand Name

CARDINAL HEALTH

Version/Model Number

CHIP99CP42

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

OEQ

Product Code Name

Angiography/angioplasty kit

Public Device Record Key

5ed3758f-3c91-4002-8ec3-18ccf744acf2

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 19, 2018

Package DI Number

50888439313831

Quantity per Package

2

Contains DI Package

10888439313833

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE