Catalog Number

BHAN91M

Brand Name

Halyard

Version/Model Number

BHAN91M_0001

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

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

0757f16c-1044-4fab-9fd4-1a45676b88f0

Public Version Date

June 15, 2022

Public Version Number

1

DI Record Publish Date

June 07, 2022

Package DI Number

20809160372453

Quantity per Package

5

Contains DI Package

10809160372456

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-