Catalog Number

SBA19TVUWH

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA19TVUWH

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

181294cb-41a0-4d55-900b-04f50db0ea7f

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2015

Package DI Number

50887488033554

Quantity per Package

2

Contains DI Package

00887488033559

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE