Catalog Number

SAN19VCUWA

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN19VCUWA

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

OKE

Product Code Name

Port introducer kit

Public Device Record Key

b165beb9-ffa9-42f2-b72b-c09937520af4

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

July 24, 2015

Package DI Number

50885425126239

Quantity per Package

10

Contains DI Package

00885425126234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE