Catalog Number

PCOCVPVBD

Brand Name

CARDINAL HEALTH

Version/Model Number

PCOCVPVBD

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

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

625e1320-edd0-4e84-a325-e9d639714708

Public Version Date

July 20, 2018

Public Version Number

2

DI Record Publish Date

March 08, 2018

Package DI Number

50887488907664

Quantity per Package

1

Contains DI Package

10887488907666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE