RESPIRONICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3002797442	3002797442	RESPIRONICS, INC.	1	Y	2026-01-01	174 Tech Center Drive Mount Pleasant PA US 15666
3007220521	3007220521	RESPIRONICS, INC.	1	N	2026-01-01	312 Alvin Drive New Kensington PA US 15068
3027553886	3027553886	Respironics, Inc.	1	N	2026-01-01	Coyol Free Zone and Business Park, Building B37 Coyol Alajuela CR 20101
3007223238	3007223238	Respironics, Inc.	1	N	2020-04-25	920 SW Emkay Drive, Suite 100 Bend OR US 97702

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00606959015203	REMSTAR PASSOVER HUMIDIFIER	+1(724)744-2500	RESPIRONICS.SERVICE@PHILIPS.COM
00606959015210	Replacement Part 24 Inch Grey Tubing - 00	+1(724)744-2500	RESPIRONICS.SERVICE@PHILIPS.COM
00606959424852	DreamStation BiPAP autoSV - DreamStation BiPAP autoSV with Humidifier, with Heated Tube, with Cell Modem, Australia	+1(724)744-2500	respironics.service@philips.com
00606959424944	DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Humidifier, with Cell Modem, Australia	+1(724)744-2500	respironics.service@philips.com
00606959424951	DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Cell Modem, Australia	+1(724)744-2500	respironics.service@philips.com

philips.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
38174	2065212743	K991725	SIDESTREAM NEBULIZER	CAF	1999-07-30
38174	1411042033	K982293	PRESSURE TRANSDUCER AIRFLOW SENSOR	MNR	1998-07-13
38174	1270319922	K962822	OPTICHAMBER	CAF	1996-10-17
38174	1950225934	K961077	PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE	BWF	1996-07-15
38174	1909719107	K924123	SIDESTREAM DISPOSABLE	CAF	1992-11-16
92932	1456947492	K914103	LIFELINE(R) PERSONAL RESPONSE SYSTEM	ILQ	1991-09-27
38174	1456947492	K914103	LIFELINE(R) PERSONAL RESPONSE SYSTEM	ILQ	1991-09-27
38174	1515004143	K870514	THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER	BWF	1987-03-31
318642	1887660724	K261262	Altis Full Face Mask	BZD	2026-09-25
318642	1599104426	K210844	DreamWear Silicone Pillows Mask	BZD	2021-08-24
38174	1671503648	K210386	Magneto Nasal Mask	BZD	2021-07-12
92932	1305965160	K200480	DreamStation 2 System, DreamStation 2 Advanced System	BZD	2020-07-10
38174	1235570543	K181170	Trilogy Evo Universal	CBK	2019-07-18
38174	1367408439	K181166	Trilogy Evo	CBK	2019-07-18
318642	1961907368	K142554	Revolution Full Face Mask	BZD	2015-01-09
38174	1980527512	K140980	TI NASAL MASK	BZD	2015-02-10
318642	1980527512	K140980	TI NASAL MASK	BZD	2015-02-10
38174	1776268550	K140268	SIMPLE T YOUTH NASAL MASK	BZD	2014-10-20
92932	1143798291	K131982	REMSTAR AUTO A-FLEX HT	BZD	2013-10-18
38174	1143798291	K131982	REMSTAR AUTO A-FLEX HT	BZD	2013-10-18
92932	1560342684	K130077	REMSTAR SE	BZD	2013-05-21
38174	1187907010	K122847	KANGAROO NASAL MASK	BZD	2013-03-06
92932	1538224266	K122769	REMSTAR SE	BZD	2012-10-09
38174	1538224266	K122769	REMSTAR SE	BZD	2012-10-09
38174	1811736981	K121631	SIMPLE T NASAL MASK	BZD	2012-10-05
318642	1811736981	K121631	SIMPLE T NASAL MASK	BZD	2012-10-05
38174	1622802605	K121623	BIPAP A 40 VENTILATORY SUPPORT SYSTEM	MNT	2012-12-14
92932	1707032613	K113068	REMSTAR AUTO A-FLEX HT	BZD	2011-12-16
38174	1707032613	K113068	REMSTAR AUTO A-FLEX HT	BZD	2011-12-16
38174	1314408761	K113053	BIPAP A 30 VENTILATORY SUPPORT SYSTEM	MNS	2012-02-01
92932	2037210991	K111885	SIMPLYGO PORTABLE OXYGEN CONCENTRATOR	CAW	2011-11-04
38174	1587768471	K110398	RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS	BZE	2011-06-01
38174	1899501073	K110293	OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER	NVP	2011-08-09
92932	1518713971	K102465	BIPAP AVAPS VENTILATORY SUPPORT SYSTEM	MNS	2011-03-24
38174	1159662292	K100285	LITETOUCH MASK	CAF	2010-06-29
38174	1899239281	K093905	TRILOGY 202 VENTILATOR	CBK	2010-05-12
38174	1897398941	K093416	TRILOGY 200 VENTILATOR	CBK	2010-01-29
38174	2035267530	K092835	COMFORTGEL NASAL MASK	BZD	2010-02-12
318642	2035267530	K092835	COMFORTGEL NASAL MASK	BZD	2010-02-12
92932	1965018902	K092818	BIPAP AVAPS VENTILATORY SUPPORT SYSTEM	MNS	2010-01-22
38174	1965018902	K092818	BIPAP AVAPS VENTILATORY SUPPORT SYSTEM	MNS	2010-01-22
38174	1792832854	K092043	BIPAP SYNCHRONY 2	MNS	2009-08-05
92932	1275429875	K091319	REMSTAR AUTO A-FLEX	BZD	2009-08-03
92932	1653708524	K091112	RESPIRONICS SLEEPEASY CPAP SYSTEM	BZD	2009-05-15
92932	1751863410	K090539	BIPAP AUTOSV ADVANCED	MNS	2009-10-30
38174	1751863410	K090539	BIPAP AUTOSV ADVANCED	MNS	2009-10-30
38174	1505410816	K090484	ALICE PDX	MNR	2009-06-26
38174	1725208571	K083874	GALAXY	MNR	2009-01-26
38174	1301059571	K083526	TRILOGY 100 VENTILATOR	CBK	2009-03-13
38174	1594016126	K082866	REVOLUTIONFULL FACE MASK	BZD	2009-01-30
38174	1222031268	K062689	SIDESTREAM PLUS	CAF	2007-02-16
216668	1089862999	K060919	ACTICAL	GWK	2006-09-22
38174	1042080886	K060404	AG-PLUS, MODEL 91210	CAF	2006-06-22
38174	1669464079	K052573	STARDUST II	MNR	2005-12-13
38174	1520760995	K051383	THE INCOURAGE SYSTEM	BYI	2005-06-17
38174	2059128678	K042655	INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456	CAF	2004-10-13
38174	2008438643	K040595	ALICE 5	OLZ	2004-03-18
38174	1040155602	K032809	HOSPITAL SPACER	CAF	2003-11-13
38174	1177357976	K023135	IMAGE3 SE DISPOSABLE FULL FACE MASK	CBK	2003-01-03
38174	1633027361	K010263	REMSTAR PLUS CPAP SYSTEM	BZD	2001-03-29
216668	1399112341
38174	1422444878
92932	1713899733

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
BZD	24	2026-09-25
CAF	8	2010-06-29
CBK	7	2019-07-18
MNS	7	2012-02-01
MNR	4	2009-06-26
BWF	2	1996-07-15
ILQ	2	1991-09-27
MNT	1	2012-12-14
CAW	1	2011-11-04
NVP	1	2011-08-09
BZE	1	2011-06-01
GWK	1	2006-09-22
BYI	1	2005-06-17
OLZ	1	2004-03-18

PMN#

AF531 Oro-Nasal SE Face Mask
2024-12-30
Respironics, Inc.
Therapy Mask 3100 NC/SP
2023-07-28
Respironics, Inc.
DreamWear Silicone Pillows Mask
2021-08-24
Respironics, Inc.
Magneto Nasal Mask
2021-07-12
Respironics, Inc.
Sleepware G3
2020-10-29
Respironics, Inc.
Ventilator, Non-continuous (Respirator)
2020-09-25
Respironics, Inc.
DreamStation 2 System, DreamStation 2 Advanced System
2020-07-10
Respironics, Inc.
SomnaPatch
2019-10-18
Respironics, Inc.
Care Cycle Connect Application
2017-02-17
RESPIRONICS, INC.
Simple T Pediatric Nasal Mask
2016-04-15
RESPIRONICS, INC.
AF541 SE Full Face Mask
2015-09-18
Respironics, Inc.
AF541 EE Full Face Mask
2015-09-18
RESPIRONICS, INC.
Sleepware G3
2015-03-16
RESPIRONICS, INC.
TI NASAL MASK
2015-02-10
RESPIRONICS, INC.
Revolution Full Face Mask
2015-01-09
Respironics, Inc.
RESPIRONICS REUSABLE HEATED TUBING
2014-11-14
RESPIRONICS, INC.
SIMPLE T YOUTH NASAL MASK
2014-10-20
RESPIRONICS, INC.
BRONCHOSCOPY ELBOW
2013-11-20
RESPIRONICS, INC.
REMSTAR AUTO A-FLEX HT
2013-10-18
RESPIRONICS, INC.
SOMNOLYZER 24X7
2013-10-17
RESPIRONICS, INC.
REMSTAR SE
2013-05-21
RESPIRONICS, INC.
RESPIRONICS SIMPLYCLEAR DEVICE
2012-12-31
RESPIRONICS, INC.
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
2012-12-14
RESPIRONICS, INC.
COUGHASSIST T70 DEVICE
2012-12-14
RESPIRONICS, INC.
REMSTAR SE
2012-10-09
RESPIRONICS, INC.
SIMPLE T NASAL MASK
2012-10-05
RESPIRONICS, INC.
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
2012-07-17
RESPIRONICS, INC.
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
2012-07-10
RESPIRONICS, INC.
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
2012-02-01
RESPIRONICS, INC.
REMSTAR AUTO A-FLEX HT
2011-12-16
RESPIRONICS, INC.
TRILOGY SERIES VENTILATOR WITH OXIMETRY
2011-10-14
RESPIRONICS, INC.
TRUBLUE NASAL MASK
2011-06-06
RESPIRONICS, INC.
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
2011-06-01
RESPIRONICS, INC.
PERFORMAX TOTAL FACE MASK
2011-03-24
RESPIRONICS, INC.
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
2011-03-24
RESPIRONICS, INC.
GOLIFE NASAL MASK
2011-02-17
RESPIRONICS, INC.
GOLIFE NASAL MASK
2010-12-22
RESPIRONICS, INC.
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
2010-09-16
RESPIRONICS, INC.
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
2010-09-02
RESPIRONICS, INC.
TRILOGY 202 VENTILATOR
2010-05-12
RESPIRONICS, INC.

161 records. Showing 1-40. Next

GUDID#

REMSTAR PASSOVER HUMIDIFIER
Respironics, Inc.
2018-06-26
Replacement Part 24 Inch Grey Tubing - 00
Respironics, Inc.
2018-06-30
Sleepware G3
Respironics, Inc.
2026-01-22
Care Orchestrator
Respironics, Inc.
2026-01-22
DreamStation BiPAP autoSV - DreamStation BiPAP autoSV with Humidifier, with Heated Tube, with Cell Modem, Australia
Respironics, Inc.
2017-02-01
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Humidifier, with Cell Modem, Australia
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Cell Modem, Australia
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Humidifier with WiFi, Australia
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with WiFi, Australia
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Humidifier, with Heated Tube, with WiFi, Australia
Respironics, Inc.
2017-02-10
DreamStation - DreamStation BiPAP AVAPS 30 AAM with Humidifier and Heated Tube, no Bluetooth, China
Respironics, Inc.
2019-12-29
DreamStation - DreamStation BiPAP AVAPS30AE with Humidifier, no Bluetooth, China
Respironics, Inc.
2019-12-29
DreamStation - DreamStation BiPAP AVAPS30AE AAM, no Bluetooth, China
Respironics, Inc.
2019-12-29
DreamStation - DreamStation BiPAP AVAPS30AE AAM with Humidifier and Heated Tube, no Bluetooth, China
Respironics, Inc.
2019-11-20
DreamStation BiPAP autoSV - DreamStation BiPAP autoSV with heated tube humidifier and cellular modem, Canada
Respironics, Inc.
2017-02-01
DreamStation BiPAP autoSV - DreamStation BiPAP autoSV, with heated tube humidifier and WiFi accessory, US
Respironics, Inc.
2017-02-01
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 with Humidifier, with Cell Modem, Canada
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 with Cell Modem, Canada
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 with Humidifier, with Heated Tube, with Cell Modem, Canada
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AAM with Humidifier, with WiFi, Canada
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AAM, with WiFi, Canada
Respironics, Inc.
2017-02-10
DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 with Humidifier, with Heated Tube, with WiFi, Canada
Respironics, Inc.
2017-02-10
DreamStation - DreamStation BiPAP AutoSV Ventilatory Support System (Great Britian/UK)
Respironics, Inc.
2017-01-27
DreamStation - DreamStation, BiPAP AutoSV with Humidifier, GB
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP autoSV, BL
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP autoSV w/Humidifier, BL
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP AutoSV, DE
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP autoSV Ventilatory Support System - Latvia
Respironics, Inc.
2017-01-27
DreamStation - DreamStation, BiPAP AutoSV with Humidifier, EE
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP autoSV, ES
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP autoSV w/Humidifier, ES
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP AutoSV EU
Respironics, Inc.
2017-01-27
DreamStation - DreamStation, BiPAP AutoSV with Humidifier, EU
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP autoSV, No Bluetooth, EU
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP autoSV with Humidifier, No Bluetooth, EU
Respironics, Inc.
2017-01-27
DreamStation - DreamStation BiPAP AutoSV, FR
Respironics, Inc.
2016-11-01
DreamStation - DreamStation BiPAP AutoSV with Humidifier, FR
Respironics, Inc.
2017-01-27
DreamStation BiPAP autoSV - DreamStation BiPAP autoSV with WiFi, France
Respironics, Inc.
2017-08-11
DreamStation - DreamStation BiPAP autoSV, ND
Respironics, Inc.
2017-01-27

200 records. Showing 1-40. Next