Catalog Number

-

Brand Name

Nasoneb®

Version/Model Number

Sinus Therapy System

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JPW

Product Code Name

Pump, Nebulizer, Electrically Powered

Public Device Record Key

fe2736e7-bc35-4533-9206-9426302ccf34

Public Version Date

April 27, 2022

Public Version Number

1

DI Record Publish Date

April 19, 2022

Package DI Number

50604351707011

Quantity per Package

1

Contains DI Package

00604351707016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-