Duns Number:785635186
Device Description: Disposable nasal non vented mask for use with non invasive ventilator system with exhalati Disposable nasal non vented mask for use with non invasive ventilator system with exhalation valves.
Catalog Number
-
Brand Name
Innova Hospital Nasal Non Vented Mask, m/l
Version/Model Number
50595
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
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
a14bd86c-707b-4f46-a4a4-d75b6c2da902
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 07, 2016
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 |