Catalog Number

KAFB016-03

Brand Name

Halyard

Version/Model Number

KAFB016-03_0003

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

c9b656ce-5ca3-486e-a231-ff5600d63c82

Public Version Date

September 07, 2022

Public Version Number

1

DI Record Publish Date

August 30, 2022

Package DI Number

20809160383237

Quantity per Package

4

Contains DI Package

10809160383230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-