Duns Number:590153276
Device Description: Nivairo Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve Version - Small
Catalog Number
RT045S
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
RT045S
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
Yes
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
MNT
Product Code Name
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Public Device Record Key
4f97105c-a79f-4637-b6ea-1118ced74e86
Public Version Date
October 14, 2019
Public Version Number
4
DI Record Publish Date
October 13, 2017
Package DI Number
09420012436108
Quantity per Package
10
Contains DI Package
09420012436092
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 |