Device product
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Z-1117-2022
Product summary
- Firm
- Caire, Inc.
- Event
- Event 90011
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 oxygen concentrators
- Official record key
device-enforcement:Z-1117-2022
Official wording
Reason: The device was not cleared for U.S. distribution.
Code information: Serial numbers CBB5221200337 and CBB5221200287.
Distribution pattern: Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Derived failure modes
-
Unknown
The device was not cleared for U.S. distribution.