Catalog Number

NE-C801

Brand Name

Omron CompAir Compressor Nebulizer

Version/Model Number

NE-C801

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

K110860,K110860

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

03bf301c-e07d-499a-8963-88b2d031c904

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

May 17, 2017

Package DI Number

10073796458017

Quantity per Package

10

Contains DI Package

00073796458010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case