Duns Number:590153276
Device Description: myAIRVO 2 Heated Breathing Tube
Catalog Number
900PT560
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
900PT560
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
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
ded298a2-c5dc-42b2-9a32-10d68158dc4f
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
May 12, 2019
Package DI Number
09420012433770
Quantity per Package
10
Contains DI Package
09420012448033
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |