Catalog Number

AMOH01AG

Brand Name

Halyard

Version/Model Number

AMOH01AG_0006

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

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

0d6ffb26-5bba-4d17-b9b2-787d31e88b11

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Package DI Number

20809160385637

Quantity per Package

2

Contains DI Package

10809160385630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-