Duns Number:785635186
Device Description: Full face non vented mask with anti-asphyxiation valve for use in positive pressure ventil Full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation.
Catalog Number
-
Brand Name
Mojo 2 Full Face AAV Non Vented Mask, XL
Version/Model Number
50944
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
031258f2-5308-41ce-8483-2860a2c3f441
Public Version Date
December 13, 2019
Public Version Number
2
DI Record Publish Date
May 03, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 217 |