Catalog Number

WRNM064-04

Brand Name

Halyard

Version/Model Number

WRNM064-04_0020

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

93bc82cf-7329-44fb-a1c2-3c12115cf4bb

Public Version Date

July 06, 2022

Public Version Number

1

DI Record Publish Date

June 28, 2022

Package DI Number

20809160374204

Quantity per Package

3

Contains DI Package

10809160374207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-