Catalog Number

SCVMVVENL2

Brand Name

CARDINAL HEALTH

Version/Model Number

SCVMVVENL2

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

d00be34f-9a76-438f-9b1e-ee1c28f55dae

Public Version Date

December 30, 2021

Public Version Number

1

DI Record Publish Date

December 22, 2021

Package DI Number

50195594491077

Quantity per Package

3

Contains DI Package

10195594491079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE