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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 5 of 7

Device	Model / Reference	Registries	Class	Status
FreeStyle Comfort	AS200-1	FDA UDI	Class II	Active
Focus	AS078-1CU	FDA UDI	Class II	Active
Stroller	10733460	FDA UDI	Class II	Active
CAIRE Inc.	AS200-41	FDA UDI	Class II	Active
CAIRE Inc.	AS200-141	FDA UDI	Class II	Active
eQuinox Oxygen Concentrator	4807-SEQ	FDA UDI	Class II	Active
Stroller	14304179	FDA UDI	Class II	Active
Stroller	14766891	FDA UDI	Class II	Active
eQuinox Oxygen Concentrator	4807C-SEQ	FDA UDI	Class II	Active
Stroller	14306730	FDA UDI	Class II	Active
Stroller	10987030	FDA UDI	Class II	Active
Sprint	10769139	FDA UDI	Class II	Active
Liberator	13259695	FDA UDI	Class II	Active
Liberator	14454978	FDA UDI	Class II	Active
Integra EZ Oxygen Concentrator	9623-SEQ	FDA UDI	Class II	Active
Stroller	14304486	FDA UDI	Class II	Active
HELiOS 36	B-702100-00	FDA UDI	Class II	Active
Stroller	14306799	FDA UDI	Class II	Active
NewLife Intensity 10	AS099-100U	FDA UDI	Class II	Active
Liberator	20534765	FDA UDI	Class II	Active
Focus	AS078-1U	FDA UDI	Class II	Active
Stroller	11008104	FDA UDI	Class II	Active
Spirit Portable Liquid Oxygen	13042980	FDA UDI	Class II	Active
Sprint	20597577	FDA UDI	Class II	Active
HOMESTYLE Aspen	SCE1000-NANB	FDA UDI	Class II	Active
VisionAire	AS098-4U	FDA UDI	Class II	Active
Liberator	13256110	FDA UDI	Class II	Active
Stroller	14308698	FDA UDI	Class II	Active
FreeStyle Comfort	AS200-1R	FDA UDI	Class II	Active
Stroller	14308591	FDA UDI	Class II	Active
Liberator	13256806	FDA UDI	Class II	Active
Stroller	14309586	FDA UDI	Class II	Active
Eclipse 3 Assembly, Re-Manufactured	5985C-SEQ	FDA UDI	Class II	Active
Arya	AS200-146	FDA UDI	Class II	Active
Arya	AS200-206	FDA UDI	Class II	Active
Spirit Portable Liquid Oxygen	13100107	FDA UDI	Class II	Active
Companion 1000	B-775532-00	FDA UDI	Class II	Active
Spirit Portable Liquid Oxygen	11751483	FDA UDI	Class II	Active
Spirit Portable Liquid Oxygen	11940233	FDA UDI	Class II	Active
Arya	AS200-6R	FDA UDI	Class II	Active
Companion 1000	B-775099-00	FDA UDI	Class II	Active
Eclipse Oxygen Concentrator	5900C-SEQ	FDA UDI	Class II	Active
AirSEP AS-N	AS092-21	EUDAMED	Class IIa	Active
Liberator	13263694	EUDAMED	Class IIa	Active
Liberator	20606186	EUDAMEDFDA UDI	Class IIa	Active
Stroller	10734067	EUDAMED	Class IIa	Active
Stroller	14306748	EUDAMED	Class IIa	Active
Liberator	13259919	EUDAMEDFDA UDI	Class IIa	Active
Hi Flow Stroller	14768299	EUDAMED	Class IIa	Active
Omni 3 Oxygen System	K120785	FDA 510(k)	Class II	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.