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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 (308)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Liberator | 13260127 | FDA UDI | Class II | Active |
| Integra EZ Oxygen Concentrator | 9621-SEQ | FDA UDI | Class II | Active |
| Stroller | 14081471 | FDA UDI | Class II | Active |
| Stroller | 10998003 | FDA UDI | Class II | Active |
| Companion 5 | 15067005R | FDA UDI | Class II | Active |
| NewLife Intensity 10 | AS099-1U | FDA UDI | Class II | Active |
| Stroller | 14769654 | FDA UDI | Class II | Active |
| Liberator | 13256582 | FDA UDI | Class II | Active |
| FreeStyle 5 | AS077-1 | FDA UDI | Class II | Active |
| Sprint | 10682842 | FDA UDI | Class II | Active |
| Sprint | 10669162 | FDA UDI | Class II | Active |
| Companion 5 | 15067005 | FDA UDI | Class II | Active |
| Stroller | 14818111 | FDA UDI | Class II | Active |
| CAIRE Inc. | AS200-241 | FDA UDI | Class II | Active |
| Companion 31 | B-775920-00 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13946508 | FDA UDI | Class II | Active |
| FreeStyle 5 | AS077-1CU | FDA UDI | Class II | Active |
| FreeStyle | AS095-1U | FDA UDI | Class II | Active |
| Eclipse Oxygen Concentrator | 6900LN-SEQ | FDA UDI | Class II | Active |
| Liberator | 13254464 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-81 | FDA UDI | Class II | Active |
| Eclipse Oxygen Concentrator | 5900-SEQ | FDA UDI | Class II | Active |
| FreeStyle Comfort | AS200-1DTC | FDA UDI | Class II | Active |
| Liberator | 13258641SM | FDA UDI | Class II | Active |
| Sprint | 10564096 | FDA UDI | Class II | Active |
| Liberator | 13256831 | FDA UDI | Class II | Active |
| Stroller | 14767270 | FDA UDI | Class II | Active |
| Stroller | 10769147 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-4U | FDA UDI | Class II | Active |
| Arya | AS200-106 | FDA UDI | Class II | Active |
| Sprint | 10733451 | FDA UDI | Class II | Active |
| Stroller | 14304540 | FDA UDI | Class II | Active |
| Liberator | 13256961SM | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13104167 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 11769747 | FDA UDI | Class II | Active |
| Stroller | 14767421 | FDA UDI | Class II | Active |
| Stroller | 13997962 | FDA UDI | Class II | Active |
| Sprint | 10997220 | FDA UDI | Class II | Active |
| Stroller | 14767448 | FDA UDI | Class II | Active |
| Sprint | 10564117 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-90 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-1U | FDA UDI | Class II | Active |
| Arya | AS200-SW46 | FDA UDI | Class II | Active |
| Stroller | 10564109 | FDA UDI | Class II | Active |
| NewLife Elite | AS005-10 | FDA UDI | Class II | Active |
| CAIRE Inc. | AS200-SW41 | FDA UDI | Class II | Active |
| Spirit Portable Liquid Oxygen | 13103130 | FDA UDI | Class II | Active |
| Liberator | 13260063 | FDA UDI | Class II | Active |
| Stroller | 14779019 | FDA UDI | Class II | Active |
| Liberator | 13364891 | 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. |