Duns Number:043833813
Device Description: Micro-Vent Radioaerosol System
Catalog Number
177-107
Brand Name
Micro-Vent
Version/Model Number
177-107
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
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
K904717,K904717,K904717,K904717
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
080788a2-d6ba-4c55-8221-14f4d6d3124a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 16, 2016
Package DI Number
30718175001104
Quantity per Package
25
Contains DI Package
00718175001073
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 193 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |