Catalog Number

SCV30ORMD1

Brand Name

CARDINAL HEALTH

Version/Model Number

SCV30ORMD1

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

PXK

Product Code Name

Vascular access port kit

Public Device Record Key

41b909b2-f43a-4238-ba4f-dbced2ddb0cc

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Package DI Number

50195594761033

Quantity per Package

2

Contains DI Package

10195594761035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE