Duns Number:785635186
Device Description: Disposable full face non vented mask with anti-asphyxiation valve for use in positive pres Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation.
Catalog Number
-
Brand Name
FitStar Full Face AAV Non Vented Mask, Large
Version/Model Number
10710
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
-
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
-
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
d9449844-3c5c-4953-bf4d-57e5806ed24b
Public Version Date
January 19, 2022
Public Version Number
1
DI Record Publish Date
January 11, 2022
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 217 |