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United States·US-MF-000013030
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2200, Airport Industrial drive, Ball Ground, United States
- Website
- www.caireinc.com
- —
- —
- [email protected]
- Phone
- +49 0 202 25859148
- PRRC Contact
- Jack Van Gaans
- EUDAMED SRN
- US-MF-000013030
- FDA FEI Number
- 2129616
- DUNS Number
- 807537683
Catalogue (308)
Page 1 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stroller | 10998054 | FDA UDI | Class II | Active |
| Stroller | 10564125 | FDA UDI | Class II | Active |
| Stroller | 14770508 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13104204 | FDA UDI | Class II | Active |
| Integra EZ Oxygen Concentrator | 9620-SEQ | FDA UDI | Class II | Active |
| Liberator | 15090379SM | FDA UDI | Class II | Active |
| Stroller | 14081198 | FDA UDI | Class II | Active |
| Liberator | 14454978SM | FDA UDI | Class II | Active |
| Arya | AS200-SW6 | FDA UDI | Class II | Active |
| Liberator | 13258588 | FDA UDI | Class II | Active |
| VisionAire 2 | AS096-8 | FDA UDI | Class II | Active |
| Stroller | 14309594 | FDA UDI | Class II | Active |
| Liberator | 13259863 | FDA UDI | Class II | Active |
| Eclipse 3 | 5909-SEQ | FDA UDI | Class II | Active |
| Stroller | 14767325 | FDA UDI | Class II | Active |
| Stroller | 10998011 | FDA UDI | Class II | Active |
| VisionAire | AS096-7 | FDA UDI | Class II | Active |
| Stroller | 14767510 | FDA UDI | Class II | Active |
| Liberator | 13259548 | FDA UDI | Class II | Active |
| HELiOS 46 | B-702099-00 | FDA UDI | Class II | Active |
| Stroller | 14765531 | FDA UDI | Class II | Active |
| FreeStyle | AS077-101 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-84 | FDA UDI | Class II | Active |
| Stroller | 14309498 | FDA UDI | Class II | Active |
| Stroller | 14777558 | FDA UDI | Class II | Active |
| Stroller | 14308575 | FDA UDI | Class II | Active |
| Liberator | 13258449SM | FDA UDI | Class II | Active |
| Stroller | 14765549 | FDA UDI | Class II | Active |
| Liberator | 20606186SM | FDA UDI | Class II | Active |
| Stroller | 14306772 | FDA UDI | Class II | Active |
| Stroller | 14308911 | FDA UDI | Class II | Active |
| VisionAire | AS098-4 | FDA UDI | Class II | Active |
| Liberator | 13258385SM | FDA UDI | Class II | Active |
| FreeStyle 5 | AS077-1U | FDA UDI | Class II | Active |
| Stroller | 11008075 | FDA UDI | Class II | Active |
| Liberator | 13254579 | FDA UDI | Class II | Active |
| NewLife Intensity 10 | AS099-101 | FDA UDI | Class II | Active |
| Liberator | 13256591 | FDA UDI | Class II | Active |
| Stroller | 14777718 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-1 | FDA UDI | Class II | Active |
| Eclipse Oxygen Concentrator | 6900BT-SEQ | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13846021 | FDA UDI | Class II | Active |
| NewLife Intensity | AS094-4U | FDA UDI | Class II | Active |
| Stroller | 14769911 | FDA UDI | Class II | Active |
| Saros 15 | AS007-1 | FDA UDI | Class II | Active |
| Liberator | 13256929SM | FDA UDI | Class II | Active |
| Liberator | 13259450 | FDA UDI | Class II | Active |
| Stroller | 11008112 | FDA UDI | Class II | Active |
| Liberator | 20551902 | FDA UDI | Class II | Active |
| HELiOS 46 | B-701652-00 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (12)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 4, 2024 | Z-0480-2025 | — | completed | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| Oct 4, 2024 | Z-0479-2025 | — | completed | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| Oct 4, 2024 | Z-0481-2025 | — | completed | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| Oct 4, 2024 | Z-0478-2025 | — | completed | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| Oct 10, 2022 | Z-0338-2023 | — | terminated | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| Oct 10, 2022 | Z-0337-2023 | — | terminated | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| Oct 10, 2022 | Z-0336-2023 | — | terminated | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| Oct 10, 2022 | Z-0339-2023 | — | terminated | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| Mar 25, 2022 | Z-1117-2022 | — | terminated | The device was not cleared for U.S. distribution. |
| Nov 21, 2019 | Z-0805-2020 | — | terminated | Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.. |
| Sep 16, 2019 | Z-0248-2020 | — | terminated | There is an electronics control issue that causes the unit to not power on with battery power only. |
| Oct 23, 2007 | Z-1716-2008 | — | terminated | Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge. |