Catalog Number

SANHFPCAC2

Brand Name

CARDINAL HEALTH

Version/Model Number

SANHFPCAC2

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

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

8b2c1feb-282e-4e18-aa4f-c27be637ba6c

Public Version Date

November 15, 2018

Public Version Number

1

DI Record Publish Date

October 15, 2018

Package DI Number

50888439231265

Quantity per Package

2

Contains DI Package

10888439231267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE