Catalog Number

NIHB0006-09

Brand Name

Halyard

Version/Model Number

NIHB0006-09_0014

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

-

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

368f74b7-0840-4e99-a7f2-44c099f03b27

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 2022

Package DI Number

20809160381264

Quantity per Package

2

Contains DI Package

10809160381267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-