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Sign in to claim this brandCAIRE INC.
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 (307)
Page 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Companion 41 | B-775930-00 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-87 | FDA UDI | Class II | Active |
| Sprint | 10768865 | FDA UDI | Class II | Active |
| Liberator | 14168314SM | FDA UDI | Class II | Active |
| Sprint | 11493074 | FDA UDI | Class II | Active |
| Liberator | 13256380 | FDA UDI | Class II | Active |
| Liberator | 13260143 | FDA UDI | Class II | Active |
| Stroller | 14081243 | FDA UDI | Class II | Active |
| NewLife Intensity | AS094-101 | FDA UDI | Class II | Active |
| Sprint | 10768662 | FDA UDI | Class II | Active |
| AirSep FreeStyle 5 | AS077-101CU | FDA UDI | Class II | Active |
| SureFlow | FM069-5 | FDA UDI | Class I | Active |
| Spirit Portable Liquid Oxygen | 13832746 | FDA UDI | Class II | Active |
| eQuinox Oxygen Concentrator | 4837-SEQ | FDA UDI | Class II | Active |
| Liberator | 13258537SM | FDA UDI | Class II | Active |
| Liberator | 13259759 | FDA UDI | Class II | Active |
| Stroller | 10987048 | FDA UDI | Class II | Active |
| Liberator | 13262026 | FDA UDI | Class II | Active |
| Arya | AS200-6 | FDA UDI | Class II | Active |
| Liberator | 13256890 | FDA UDI | Class II | Active |
| Freestyle | AS095-101 | FDA UDI | Class II | Active |
| Liberator | 13548243SM | FDA UDI | Class II | Active |
| Eclipse Oxygen Concentrator | 6900C-SEQ | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13091175 | FDA UDI | Class II | Active |
| Liberator | 13260178 | FDA UDI | Class II | Active |
| Arya | AS200-246 | FDA UDI | Class II | Active |
| Liberator | 13256996SM | FDA UDI | Class II | Active |
| Stroller | 10768671 | FDA UDI | Class II | Active |
| Liberator | 13263686 | FDA UDI | Class II | Active |
| VisionAire 3 | AS096-6 | FDA UDI | Class II | Active |
| Stroller | 11008091 | FDA UDI | Class II | Active |
| Liberator | 13258633 | FDA UDI | Class II | Active |
| VisionAire | AS098-1U | FDA UDI | Class II | Active |
| Stroller | 14309519 | FDA UDI | Class II | Active |
| Stroller | 14081227 | FDA UDI | Class II | Active |
| Liberator | 13259652 | FDA UDI | Class II | Active |
| Stroller | 14767309 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13846013 | FDA UDI | Class II | Active |
| NewLife Intensity 10 | AS099-4 | FDA UDI | Class II | Active |
| Liberator | 13259505 | FDA UDI | Class II | Active |
| FreeStyle | AS095-1 | FDA UDI | Class II | Active |
| Arya | AS200-46 | FDA UDI | Class II | Active |
| NewLife Intensity 10 | AS099-100 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13042971 | FDA UDI | Class II | Active |
| Liberator | 13262245 | FDA UDI | Class II | Active |
| Liberator | 13259847 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 11940532 | FDA UDI | Class II | Active |
| Companion 5 | 15067013R | FDA UDI | Class II | Active |
| VisionAire | AS098-707 | FDA UDI | Class II | Active |
| NewLife Intensity 10 | AS099-101U | 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. |