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
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Extra Large Adult
Version/Model Number
22780
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
603005b4-b5bd-45db-bf9c-5b8913ce1171
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 23, 2017
Package DI Number
00814747021316
Quantity per Package
8
Contains DI Package
00814747021309
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |