Catalog Number

SCVOCSIVHB

Brand Name

CARDINAL HEALTH

Version/Model Number

SCVOCSIVHB

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

a98a6f00-cb08-4adc-929c-9e6f7a9527ef

Public Version Date

July 27, 2018

Public Version Number

2

DI Record Publish Date

June 26, 2018

Package DI Number

50887488979715

Quantity per Package

6

Contains DI Package

10887488979717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE