Catalog Number

NE-U100

Brand Name

Omron MicroAir Vibrating Mesh Nebulizer

Version/Model Number

NE-U100

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

K062263,K062263

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

cc143d40-1fba-433d-b3ea-a47926ff2679

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 22, 2018

Package DI Number

10073796451001

Quantity per Package

10

Contains DI Package

00073796451004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case