Duns Number:783518983
Device Description: The Nasal irrigator is used to clean mucus from nasal passage making medication more effec The Nasal irrigator is used to clean mucus from nasal passage making medication more effective. It can also help to clean allergens, irritants, bacteria and viruses from the nose, reducing the frequency of infection as well as decreasing swelling in the nose and increasing air flow.
Catalog Number
7508
Brand Name
Easy Air Mini Sinus Irrigation System
Version/Model Number
NI-50
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMA
Product Code Name
Irrigator, Powered Nasal
Public Device Record Key
5438926f-ec09-4447-9ec4-54d579b4b11b
Public Version Date
September 30, 2019
Public Version Number
1
DI Record Publish Date
September 20, 2019
Package DI Number
10850632007505
Quantity per Package
32
Contains DI Package
00850632007508
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |