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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 (307)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sprint | 10845218 | EUDAMED | Class IIa | Active |
| NewLife Intensity 10 | AS099-10 | EUDAMED | Class IIa | Active |
| Freestyle Comfort | AS200-2 | EUDAMED | Class IIa | Active |
| Spirit | 11897386 | EUDAMEDFDA 510(k) | Class IIa | Active |
| AirSEP AS-K | AS106-21 | EUDAMED | Class IIa | Active |
| Spirit | 12944586 | EUDAMED | Class IIa | Active |
| AirSEP AS-G | AS104-21 | EUDAMED | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
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Notified Bodies
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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. |