Duns Number:092673953
Device Description: VixOne Nebulizer with Adult Aerosol Mask (With Single Vents)
Catalog Number
-
Brand Name
MADA Aerosol Mask Kits
Version/Model Number
50310
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
Yes
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
K800562,K800562
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
e1bdb1b6-6464-4ac1-a233-2abb84af92ae
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 16, 2016
Package DI Number
10709078001960
Quantity per Package
50
Contains DI Package
00709078001963
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |