Duns Number:092673953
Device Description: Aerosol Drug Delivery System, contains 1 reusable Vixone and 1 Nebulizer compressor
Catalog Number
-
Brand Name
Vixone Reusable Nebulizer
Version/Model Number
0398
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)
-
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
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
f6ae46aa-9fc6-4cbd-8297-46f3f5de04e8
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
July 24, 2017
Package DI Number
10709078004602
Quantity per Package
1
Contains DI Package
00709078004605
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 |