Duns Number:590153276
Device Description: Optiflow Thrive Anaesthesia Filtered Cannula Large
Catalog Number
AA001L
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
AA001L
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
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
a8ce3b36-03f7-47ce-82ad-9706968d00c8
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
September 08, 2016
Package DI Number
09420012435583
Quantity per Package
10
Contains DI Package
09420012435590
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 |