Catalog Number

SAN22EPCLI

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN22EPCLI

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

5a898758-5424-471c-a18e-ae3dcdc5b701

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

Package DI Number

50195594977595

Quantity per Package

4

Contains DI Package

10195594977597

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE