Catalog Number

PCSVHVHM2

Brand Name

CARDINAL HEALTH

Version/Model Number

PCSVHVHM2

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)

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

ab51c89f-572f-4a12-b5f4-e5733d0a51c8

Public Version Date

November 29, 2018

Public Version Number

1

DI Record Publish Date

October 29, 2018

Package DI Number

50888439238486

Quantity per Package

2

Contains DI Package

10888439238488

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE