Duns Number:590153276
Device Description: Optiflow Nasal Filtered Interface with CO2 Sampling Medium
Catalog Number
AA031JM
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
AA031JM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K201723,K201723
Product Code
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
5aee60e6-cc34-4301-ab2b-3c7a7faec203
Public Version Date
June 09, 2022
Public Version Number
1
DI Record Publish Date
June 01, 2022
Package DI Number
09420012470959
Quantity per Package
10
Contains DI Package
09420012470942
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 |