Catalog Number

SCV30CWGAA

Brand Name

CARDINAL HEALTH

Version/Model Number

SCV30CWGAA

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

PEZ

Product Code Name

Central venous catheter dressing change kit

Public Device Record Key

eb1fcbcc-adfc-4590-a3a9-a7265a3c2816

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

November 10, 2020

Package DI Number

50888439937556

Quantity per Package

5

Contains DI Package

10888439937558

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE