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Respironics, Inc.

United States·US-MF-000002301

Last updated September 17, 2026

Information

Country: United States
Address: 1001, Murry Ridge Lane, Murrysville, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Melissa Rosko
EUDAMED SRN: US-MF-000002301
FDA FEI Number: 3007220521
DUNS Number: 080728314

Catalogue (3774)

Page 46 of 76

Device	Model / Reference	Registries	Class	Status
Wisp	Wisp Mask, Fabric Frame, without headgear, Petite, US	FDA UDI	Class II	Active
Amara View	Amara View Mask with Headgear, Small	FDA UDI	Class II	Active
Alice NightOne	Alice NightOne, Non-Wireless, Global	FDA UDI	Class II	Active
BiPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced with Humidifier, 60 Series, LA	FDA UDI	Class II	Unknown
Af531	00606959007352	FDA UDI	Class II	Unknown
Millennium M10	Millennium M10 Oxygen Percentage Indicator Concentrator, CA	FDA UDI	Class II	Unknown
Trilogy	00	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Pro, CA	FDA UDI	Class II	Active
Af531	A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, SU	FDA UDI	Class II	Active
CoughAssist	CoughAssist, E70, INTL	FDA UDI	Class II	Active
DreamStation BiPAP autoSV	DreamStation BiPAP autoSV, no Bluetooth, BR	FDA UDI	Class II	Unknown
BiPAP A40	NDX3000S19	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP w/Humid, w/H Tube, w/Cell, CA	FDA UDI	Class II	Active
Sensor	TWO CHANNEL PLUS KIT ADULT 1.5"	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro with Humidifier, ZA	FDA UDI	Class II	Active
Care Orchestrator	CARE ORCHESTRATOR	FDA UDI	Class II	Active
DreamStation and System One	00	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, w/HT Humid System One 60 Series US	FDA UDI	Class II	Active
BiPAP autoSV Advanced System One 60 Series	BiPAP autoSV Advanced System One, 60 Series, AHP	FDA UDI	Class II	Active
PerforMax	PerforMax Mask with SE, Single Patient Use, INTL, Large	FDA UDI	Class II	Active
DreamMapper	2.17	FDA UDI	Class II	Active
DreamWear	1137467	FDA UDI	Class II	Active
DreamMapper	2.6	FDA UDI	Class I	Active
Alice 6	ALICE 6	FDA UDI	Class II	Active
DreamStation	DreamStation Wi-Fi Accessory, US	FDA UDI	Class I	Active
Af531	AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Sm, SU	FDA UDI	Class II	Active
Pro-Flow	PRO-FLOW NASAL CANNULA, ADULT 8.25"	FDA UDI	Class II	Active
DreamMapper Mobile App Android (EMEA)	2.5	FDA UDI	Class I	Active
REMstar System One 60 Series	REMstar Auto A-Flex W/SD Card JP	FDA UDI	Class II	Unknown
REMstar System One 60 Series	REMstar Pro C-Flex+, w/Humid, System One 60 Srs, SE	FDA UDI	Class II	Active
DreamStation	DreamStation Cellular Modem with Oximetry, US	FDA UDI	Class I	Active
Ap111	AP111 Mask w/Hdgr, Circuit, Filter, SU, Cradles (S,M,L,LN)	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Plus C-Flex, System One 60 Series, GB	FDA UDI	Class II	Active
BiPAP A40	00	FDA UDI	Class II	Active
Wisp	Wisp Mask, Fabric Frame with Headgear, XLarge, INTL	FDA UDI	Class II	Active
A Series Heated Humidifier	BiPAP A Series, System One Heated Humidifier, JP	FDA UDI	Class II	Unknown
DreamStation Go	CAG500H12	FDA UDI	Class II	Active
EverFlo	EVERFLO QUIET w/O2 Percent Indicator, 120V, US, CA	FDA UDI	Class II	Active
OmniLab Advanced Plus	OmniLab Advanced Plus with Humidifier, KR	FDA UDI	Class II	Unknown
Af541	AF541 Mask EE, Leak 1, Under the Nose, Capstrap, Size B, US	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP Pro with Humidifier, EU	FDA UDI	Class II	Active
Trilogy 100	Trilogy 100 W/ Bluetooth, USA	FDA UDI	Class II	Active
DreamStation	DreamStation, Cellular Modem with Oximetry, JP	FDA UDI	Class I	Unknown
Af541	AF541 Mask EE, Leak 1, w/ 4 Point Headgear, Small	FDA UDI	Class II	Active
PerforMax	Performax Mask EE, MPU, Leak 2, Small, USA	FDA UDI	Class II	Active
REMstar SE	REMstar SE w/HTD Humid, St Tube, with SD Slot, CA	FDA UDI	Class II	Active
Performatrak	PerformaTrak Mask with SE, Small, Reusable Pack, INTL	FDA UDI	Class II	Active
RUSleeping RTS	RUSleeping RTS, US	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, w/H T Hum, St Tube, BTooth, 60 Srs, CA	FDA UDI	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Respironics, Inc. Coyol Alajuela · CR FEI 3027553886