Catalog Number

SCV35DM371

Brand Name

CARDINAL HEALTH

Version/Model Number

SCV35DM371

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

b4c2a41d-ff40-46c0-b563-8e48368f885b

Public Version Date

January 12, 2022

Public Version Number

1

DI Record Publish Date

January 04, 2022

Package DI Number

50195594488831

Quantity per Package

4

Contains DI Package

10195594488833

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE