Duns Number:590153276
Device Description: F&P 850 AirSpira Adult NIV and NHF circuit kit
Catalog Number
850A61J
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
850A61J
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
K212031,K212031
Product Code
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
2cf85cc4-4099-4df2-9451-676986882d20
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
June 25, 2022
Package DI Number
09420012469014
Quantity per Package
10
Contains DI Package
09420012469021
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 |