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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 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Liberator | 13259492 | FDA UDI | Class II | Active |
| Sprint | 10997406 | FDA UDI | Class II | Active |
| Saros Oxygen Concentrator | 9400R-SEQ | FDA UDI | Class II | Active |
| NewLife Intensity | AS094-100 | FDA UDI | Class II | Active |
| Stroller | 20551921 | FDA UDI | Class II | Active |
| Stroller | 10997991 | FDA UDI | Class II | Active |
| SureFlow | FM069-1 | FDA UDI | Class I | Active |
| Stroller | 10987064 | FDA UDI | Class II | Active |
| Stroller | 14779254 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 11811466 | FDA UDI | Class II | Active |
| Liberator | 13263782 | FDA UDI | Class II | Active |
| Liberator | 13254552 | FDA UDI | Class II | Active |
| FreeStyle Comfort | AS200-SW3 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13070569 | FDA UDI | Class II | Active |
| Stroller | 14777591 | FDA UDI | Class II | Active |
| Liberator | 13258406SM | FDA UDI | Class II | Active |
| VisionAire | AS098-710 | FDA UDI | Class II | Active |
| Focus | AS078-1 | FDA UDI | Class II | Active |
| FreeStyle Comfort | AS200-101 | FDA UDI | Class II | Active |
| FreeStyle | AS095-1CU | FDA UDI | Class II | Active |
| Liberator | 13256822 | FDA UDI | Class II | Active |
| Stroller | 14190651 | FDA UDI | Class II | Active |
| Stroller | 10987056 | FDA UDI | Class II | Active |
| Liberator | 13256996 | FDA UDI | Class II | Active |
| Liberator | 13260135 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-4 | FDA UDI | Class II | Active |
| Sprint | 10997211 | FDA UDI | Class II | Active |
| VisionAire | AS098-1 | FDA UDI | Class II | Active |
| Stroller | 11928402 | FDA UDI | Class II | Active |
| NewLife Intensity 10 | AS099-4U | FDA UDI | Class II | Active |
| NewLife Intensity | AS094-1 | FDA UDI | Class II | Active |
| Integra EZ Oxygen Concentrator | 9622-SEQ | FDA UDI | Class II | Active |
| VisionAire 3 | AS096-7U | FDA UDI | Class II | Active |
| Companion 5 | 15067013 | FDA UDI | Class II | Active |
| Liberator | 13259468SM | FDA UDI | Class II | Active |
| NewLife Elite | AS005-7 | FDA UDI | Class II | Active |
| NewLife Intensity | AS094-4 | FDA UDI | Class II | Active |
| Ems | 11854984 | FDA UDI | Class II | Active |
| NewLife Intensity | AS094-1U | FDA UDI | Class II | Active |
| NewLife Intensity 10 | AS099-1 | FDA UDI | Class II | Active |
| Stroller | 14768512 | FDA UDI | Class II | Active |
| Stroller | 14304515 | FDA UDI | Class II | Active |
| HELiOS 36 | B-701653-00 | FDA UDI | Class II | Active |
| IntenOxy 5 | 21499734 | FDA UDI | Class II | Active |
| Stroller | 10734278 | FDA UDI | Class II | Active |
| Liberator | 14454960SM | FDA UDI | Class II | Active |
| Eclipse Oxygen Concentrator | 6900-SEQ | FDA UDI | Class II | Active |
| FreeStyle Comfort | AS200-201 | FDA UDI | Class II | Active |
| VisionAire | AS098-719 | FDA UDI | Class II | Active |
| Liberator | 13262190 | FDA UDI | Class II | Active |
Related Companies
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Importers
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Authorities
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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. |