Catalog Number

9920

Brand Name

Omron A.I.R.S. Adult Aerosol Mask

Version/Model Number

9920

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

-

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

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

b2dc3b15-0b56-41cf-8d7e-1cf8fb5583a8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 17, 2017

Package DI Number

10073796099203

Quantity per Package

50

Contains DI Package

00073796099206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case