Catalog Number

NE-C803

Brand Name

Omron CompAir Mini-Nebulizer

Version/Model Number

NE-C803

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

K141140,K141140

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

907f4515-d7e6-4038-9989-44f21c35f6bc

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

May 17, 2017

Package DI Number

10073796458031

Quantity per Package

10

Contains DI Package

00073796458034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case