Catalog Number

AVMD028-01

Brand Name

Halyard

Version/Model Number

AVMD028-01_0004

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

2bd2b3fa-1002-48c3-ae16-fd68026efc2f

Public Version Date

June 03, 2021

Public Version Number

1

DI Record Publish Date

May 26, 2021

Package DI Number

20809160351403

Quantity per Package

25

Contains DI Package

10809160351406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-