Catalog Number

BAHA004-07

Brand Name

Halyard

Version/Model Number

BAHA004-07_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"

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

OGD

Product Code Name

Custom anesthesia tray

Public Device Record Key

9dcaa1e8-9811-4800-b71a-a7b891b06d63

Public Version Date

May 25, 2022

Public Version Number

1

DI Record Publish Date

May 17, 2022

Package DI Number

20809160371364

Quantity per Package

10

Contains DI Package

10809160371367

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-