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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 41 of 76

Device	Model / Reference	Registries	Class	Status
BiPAP A40	FRX3000S14	FDA UDI	Class II	Active
Dorma 500	00	FDA UDI	Class II	Active
BiPAP AVAPS	BiPAP AVAPS C Series, 30cm, SE	FDA UDI	Class II	Active
DreamStation	DreamStation Auto BiPAP with Humidifier, CN	FDA UDI	Class II	Unknown
Sensor	SPI SEN.DC W.1.5MM SAFETY CONN.	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar AutoA-Flex with Humidifier, System One 60 Series, ES	FDA UDI	Class II	Active
Af541	AF541 Mask EE, Leak 1, with Capstrap, XLarge, US	FDA UDI	Class II	Active
SimplyGo	SimplyGo, US	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto A-Flex, with Humidifier, 60 Series, AU	FDA UDI	Class II	Unknown
DreamStation	DreamStation BiPAP autoSV with Humidifier, ND	FDA UDI	Class II	Active
BiPAP System One 60 Series	BiPAP Auto BiFlex, with Humidifier, System One 60 Series, SE	FDA UDI	Class II	Active
DreamStation	DreamStation Heated Humidifier, FR	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto, BR	FDA UDI	Class II	Unknown
BiPAP System One 60 Series	BiPAP Pro BiFlex, 60 Series, CA	FDA UDI	Class II	Active
Sensor	CT2 EFFORT SENSOR,PEDIATRIC,ALICE 5,RESP	FDA UDI	Class II	Active
zRIP	ZRIP	FDA UDI	Class II	Active
Performatrak	PerformaTrak Mask with SE, Large, Reusable Pack, INTL	FDA UDI	Class II	Active
EncorePro	2.21	FDA UDI	Class II	Active
Dorma	507V	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class II	Active
Wisp	1137370	FDA UDI	Class II	Active
DreamWear	00	FDA UDI	Class II	Active
Wisp	1118065	FDA UDI	Class II	Active
EverFlo	EverFlo w/Oxygen Percentage Indicator, 230V, CH	FDA UDI	Class II	Active
Af541	AF541 Mask with SE, WITH 4-PT HEADGEAR, X-LARGE	FDA UDI	Class II	Active
Alice 6	Alice 6 Base Station, LDE with Masimo, INTL	FDA UDI	Class II	Active
DreamStation	DreamStation CPAP Pro with Humidifier, KR	FDA UDI	Class II	Unknown
BiPAP System One 60 Series	BiPAP Auto BlueTooth, CA	FDA UDI	Class II	Active
REMstar SE	REMstar SE Auto with Humidifier, with SD Slot, US	FDA UDI	Class II	Unknown
Trueblue	00	FDA UDI	Class II	Unknown
DreamStation	DreamStation CPAP w/Humidifier/Cellular, AR	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Auto A-Flex w/Hum, System One 60 Series, ZA	FDA UDI	Class II	Active
DreamStation	DreamStation Heated Humidifier, DE	FDA UDI	Class II	Active
Af421	AF421 Mask with Entrainment Elbow, Leak 1, XLarge, INTL	FDA UDI	Class II	Active
REMstar System One 60 Series	REMstar Pro C-Flex+, w/H Tube Humid, 60 Series, CA	FDA UDI	Class II	Active
DreamStation	DreamStation Heated Humidifier, TR	FDA UDI	Class II	Active
Amara	AMARA MASK w/SE, with RS FRAME, RS Headgear, Petite, JP	FDA UDI	Class II	Unknown
BiPAP A40	IAX3100T19	FDA UDI	Class II	Active
DreamStation	DreamStation, BiPAP S/T30, FR	FDA UDI	Class II	Active
Sensor	THERMISTOR AIRFLOW SENSOR,1 CH, NEONATE RESP	FDA UDI	Class II	Active
DreamStation	00	FDA UDI	Class II	Active
DreamStation	DreamStation BiPAP S/T 30 AAM, EU	FDA UDI	Class II	Active
DreamMapper	2.8	FDA UDI	Class II	Active
DreamMapper Mobile App Android (EMEA)	2.10	FDA UDI	Class II	Active
OmniLab Advanced Plus	OmniLab Advanced Plus w/H Tube Humid, JP	FDA UDI	Class II	Unknown
ComfortGel Blue	ComfortGel Blue Full Mask, Small, Japan	FDA UDI	Class II	Unknown
Trilogy	R1119867	FDA UDI	Class I	Active
Cbl, High Lev Out, 18 M Ph	CBL	FDA UDI	Class II	Active
Af541	AF541 Mask, EE, Leak 2, UnderNose, w/CAPSTRAP, SIZE B	FDA UDI	Class II	Active
PerformaTrak	PerformaTrak SE Mask w 4 PT Headgear, SU, Medium, CN	FDA UDI	Class II	Unknown

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FDA Establishments (1)

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Respironics, Inc. Coyol Alajuela · CR FEI 3027553886