Duns Number:785635186
Device Description: Disposable full face non vented mask for use in positive pressure ventilation.
Catalog Number
-
Brand Name
Varifit NIV Non Vented Mask, Large Adult
Version/Model Number
22670
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
e67c214b-1dca-4d56-a03b-8f8f12a574c5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 13, 2016
Package DI Number
00814747021361
Quantity per Package
8
Contains DI Package
00814747021248
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 |