Duns Number:590153276
Device Description: F&P Vitera Full Face Mask - Medium/ Large SL For Bi-level ventilation
Catalog Number
VIT1MLSL
Brand Name
FISHER & PAYKEL HEALTHCARE
Version/Model Number
VIT1MLSL
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"
-
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
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
94cebfc1-9f79-4a9f-b700-f2afeee9c8ab
Public Version Date
November 16, 2020
Public Version Number
2
DI Record Publish Date
November 02, 2019
Package DI Number
09420012449498
Quantity per Package
10
Contains DI Package
09420012448200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 159 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |