Catalog Number

-

Brand Name

Cardiovascular Procedure Kit

Version/Model Number

74491

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 17, 2020

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

-

Product Code Name

-

Public Device Record Key

a5a9dc23-9682-4208-9403-6ecf6f89618a

Public Version Date

September 21, 2020

Public Version Number

3

DI Record Publish Date

October 08, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-