Duns Number:603158390
Device Description: Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Navy
Catalog Number
-
Brand Name
AIR INNOVATIONS
Version/Model Number
MH-906
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
KFZ
Product Code Name
Humidifier, Non-Direct Patient Interface (Home-Use)
Public Device Record Key
0a56a8ed-235e-4549-ad7e-5d5a0c6f4e78
Public Version Date
October 18, 2019
Public Version Number
1
DI Record Publish Date
October 10, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 81 |