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CAIRE 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
LinkedIn: —
Facebook: —
Email: [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 6 of 7

Device	Model / Reference	Registries	Class	Status
Modification To: Spirit	K080023	FDA 510(k)	Class II	Active
Spirit 300	K013251	FDA 510(k)	Class II	Active
Model Delta, Om Oxygen Concentrator	K952268	FDA 510(k)	Class II	Active
AirSEP AS-J	AS105-21	EUDAMED	Class IIa	Active
Liberator	14454994	EUDAMED	Class IIa	Active
Hi Flow Stroller	14081315	EUDAMED	Class IIa	Active
Liberator	13262253	EUDAMEDFDA UDI	Class IIa	Active
SureFlow	FM069-2	EUDAMEDFDA UDI	Class IIa	Active
AirSEP AS-D+	AS097-21	EUDAMED	Class IIa	Active
Liberator	13256654	EUDAMEDFDA UDI	Class IIa	Active
Liberator	13256195	EUDAMEDFDA UDI	Class IIa	Active
Liberator	20651170	EUDAMEDFDA UDI	Class IIa	Active
Stroller	14779060	EUDAMEDFDA UDI	Class IIa	Active
AirSEP AS-E	AS103-21	EUDAMED	Class IIa	Active
NewLife Intensity 8	AS094-103	EUDAMED	Class IIa	Active
Liberator	13259599	EUDAMEDFDA UDI	Class IIa	Active
Helios	H850EU	EUDAMEDFDA UDI	Class IIa	Active
Liberator	13261699	EUDAMEDFDA UDI	Class IIa	Active
Liberator	13258641	EUDAMEDFDA UDI	Class IIa	Active
Stroller	14768264	EUDAMEDFDA UDI	Class IIa	Active
Stroller	12993791	EUDAMED	Class IIa	Active
Liberator	13262085	EUDAMEDFDA UDI	Class IIa	Active
Sprint	11928429	EUDAMEDFDA UDI	Class IIa	Active
AirSEP AS-L	AS107-21	EUDAMED	Class IIa	Active
Liberator	13337403	EUDAMEDFDA UDI	Class IIa	Active
VisionAire 5	AS098-7	EUDAMED	Class IIa	Active
Helios	U36EU	EUDAMED	Class IIa	Active
Respiratory And Anaesthesia Devices - Other	13256435	EUDAMEDFDA UDI	Class IIa	Active
Sprint	20600823	EUDAMED	Class IIa	Active
NewLife Elite	AS005-555	EUDAMED	Class IIa	Active
Hi Flow Stroller	20663674	EUDAMED	Class IIa	Active
Liberator	14454986	EUDAMEDFDA UDI	Class IIa	Active
Hi Flow Stroller	14778770	EUDAMED	Class IIa	Active
Liberator	14454960	EUDAMEDFDA UDI	Class IIa	Active
Stroller	11933113	EUDAMED	Class IIa	Active
Stroller	10845200	EUDAMED	Class IIa	Active
Liberator	13263758	EUDAMEDFDA UDI	Class IIa	Active
Hi Flow Stroller	14089341	EUDAMED	Class IIa	Active
Freestyle Comfort	AS200-102	EUDAMED	Class IIa	Active
Companion 5	15067021	EUDAMEDFDA 510(k)	Class IIa	Active
Liberator	13258537	EUDAMED	Class IIa	Active
Stroller	11908161	EUDAMED	Class IIa	Active
Helios	B-700848-00	EUDAMEDFDA UDI	Class IIa	Active
Liberator	13261728	EUDAMED	Class IIa	Active
Eclipse	6900-08-SEQ	EUDAMED	Class IIa	Active
Liberator	13258449	EUDAMEDFDA UDI	Class IIa	Active
Liberator	13263811	EUDAMEDFDA UDI	Class IIa	Active
Liberator	13256929	EUDAMEDFDA UDI	Class IIa	Active
Sprint	10956671	EUDAMED	Class IIa	Active
Saros	9400-01-SEQ	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

MPS Medical Product Service GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.