Duns Number:590153276
Device Description: Nivairo RT047 Vented Hospital Full Face Mask , Anti-Asphyxiation Valve Version- Extra Smal Nivairo RT047 Vented Hospital Full Face Mask , Anti-Asphyxiation Valve Version- Extra Small
Catalog Number
RT047XS
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
RT047XS
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
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
8d7b35cd-8e78-45bf-b9b9-89855b13c661
Public Version Date
August 10, 2022
Public Version Number
1
DI Record Publish Date
August 02, 2022
Package DI Number
09420012454973
Quantity per Package
10
Contains DI Package
09420012455062
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 |