Catalog Number

OMA-8652

Brand Name

DATEX-OHMEDA

Version/Model Number

OMA-8652

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

-

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

CAM

Product Code Name

Yoke Assembly, Medical Gas

Public Device Record Key

7949c862-da9f-402b-8c29-9cd38fc9ff7e

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Package DI Number

B929OMA86521

Quantity per Package

50

Contains DI Package

B929OMA86520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX