Catalog Number

C900

Brand Name

Omron Nebulizer Kit with Air Tube and Mouthpiece

Version/Model Number

C900

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

K060811,K060811

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

84f16fbf-af42-435d-a372-295639de463a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 17, 2017

Package DI Number

10073796390003

Quantity per Package

50

Contains DI Package

00073796390006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case