FDA.report

RESPIRONICS NOVAMETRIX, LLC

Matched from indexed company URL: RESPIRONICS, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12193241219324RESPIRONICS NOVAMETRIX, LLC1Y2026-01-013000 Minuteman Rd. Andover MA US 01810
25184222518422RESPIRONICS INC.1N2026-01-011001 Murry Ridge Lane MURRYSVILLE PA US 15668
30014003103001400310Respironics Deutschland GmbH & Co.KG1N2026-01-01Gewerbestr. 17 Herrsching Bavaria DE 82211
30027974423002797442RESPIRONICS, INC.1Y2026-01-01174 Tech Center Drive Mount Pleasant PA US 15666
30072205213007220521RESPIRONICS, INC.1N2026-01-01312 Alvin Drive New Kensington PA US 15068
30275538863027553886Respironics, Inc.1N2026-01-01Coyol Free Zone and Business Park, Building B37 Coyol Alajuela CR 20101
30385623973038562397Respironics Medical Products (Shenzhen) Co., Ltd.1N2026-01-01101, 201, 301-B, Building 1, Park 1, Xin Qiao Dong Advanced Indu Hong Tian Community, Xin Qiao Sub-district, Bao Shenzhen Guangdong CN 518125
20316423002470603RESPIRONICS CALIFORNIA, LLC1N2020-04-252271 Cosmos Ct CARLSBAD CA US 92011
30072232383007223238Respironics, Inc.1N2020-04-25920 SW Emkay Drive, Suite 100 Bend OR US 97702
30090152093009015209Respironics, Inc., LA Service Center1N2020-04-2514101 Rosecrans Avenue, Unit F La Mirada CA US 90638

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
00606959424852DreamStation BiPAP autoSV - DreamStation BiPAP autoSV with Humidifier, with Heated Tube, with Cell Modem, Australia+1(724)744-2500respironics.service@philips.com
00606959424944DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Humidifier, with Cell Modem, Australia+1(724)744-2500respironics.service@philips.com
00606959424951DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Cell Modem, Australia+1(724)744-2500respironics.service@philips.com
00606959424968DreamStation BiPAP AVAPS - DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia+1(724)744-2500respironics.service@philips.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
381681432014507K992969RESPIRONICS TOTAL FACE MASKBZD1999-11-10
865321297887063K992101CRITERION 40 OR PM 40CAP2000-01-06
381682065212743K991725SIDESTREAM NEBULIZERCAF1999-07-30
381742065212743K991725SIDESTREAM NEBULIZERCAF1999-07-30
381681294573549K991648REUSABLE CONTOUR II NASAL MASKBZD1999-05-28
381681041167838K991105ECG ELECTRODE (VARIOUS)DRX1999-11-26
381681633556138K991033ACTIWATCH-SCOREGWQ1999-06-23
381681756428383K983533ACTIWATCHGWQ1999-03-23
381681053529754K982454BIPAP VISION VENTILATORY SUPPORTMNT1998-11-03
381681411042033K982293PRESSURE TRANSDUCER AIRFLOW SENSORMNR1998-07-13
381741411042033K982293PRESSURE TRANSDUCER AIRFLOW SENSORMNR1998-07-13
865321087570410K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WHBYE1999-03-09
381682011311460K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WHBYE1999-03-09
381681043012843K964653OASIS HUMIDIFIERBTT1997-02-14
381681736671402K963380CO 2 SMO PLUSBZC1997-01-22
865321408683575K963327TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610CCK1996-11-20
381681665122676K963250PRESSURE VALVEBZD1996-11-14
381681765971878K962924PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEMBZH1996-10-25
381681270319922K962822OPTICHAMBERCAF1996-10-17
381741270319922K962822OPTICHAMBERCAF1996-10-17
381682026622363K962203WHISPER SWIVEL II EXHALATION PORTBZD1996-12-05
381681950225934K961077PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICEBWF1996-07-15
381741950225934K961077PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICEBWF1996-07-15
381681267611680K960851THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSORBZQ1996-09-17
381681004210105K953392HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)BTT1996-03-12
865321045850173K950397SYSTEM 22 VALVEBYE1995-04-14
381681196356221K950397SYSTEM 22 VALVEBYE1995-04-14
381681328089012K945782HUMIDIFIERBTT1996-03-01
381681011816563K944175ADAM SHELL THERMOCOUPLE ASSEMBLYBZG1994-10-14
381681529982471K940888SYSTEM 22 PAEDIATRIC MASKBYG1994-04-19
381681900260610K940015SNORING MICROPHONE, SM1MNR1995-01-11
381681034534354K940014PLM SENSOR, MODEL PLM1BZQ1994-11-10
381681785072792K940013BODY POSITION INDICATOR, MODEL BPI1MNR1995-05-04
381681702899824K933889PERSONAL BEST LOW RANGEBZH1993-09-09
381681909719107K924123SIDESTREAM DISPOSABLECAF1992-11-16
381741909719107K924123SIDESTREAM DISPOSABLECAF1992-11-16
381681034132785K923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSORBZQ1992-12-30
381681788653294K915460HEATED RESPIRATORY HUMIDIFIER HC100BTT1993-01-15
381741456947492K914103LIFELINE(R) PERSONAL RESPONSE SYSTEMILQ1991-09-27
929321456947492K914103LIFELINE(R) PERSONAL RESPONSE SYSTEMILQ1991-09-27
381681089938887K913423LIFECARE REMOTE ALARM IICBK1992-01-30
381681432967230K913396CANNULA STYLE THERMOCOUPLESBZG1992-05-22
381681946103578K913395EZ-1 SYSTEM RESPIRATORY EFFORT SENSORSBZG1992-05-20
381681965191633K913367MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESSBTT1992-06-25
381681323729720K910947NEV-10 NEGATIVE PRESSURE VENTILATORBYT1991-06-03
2166661323729720K910947NEV-10 NEGATIVE PRESSURE VENTILATORBYT1991-06-03
865321601561334K910019NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MONCCK1991-03-26
381682028131891K904935RESPIRONICS' DIGITAL MANOMETERCAP1991-04-03
381681602657568K902292MODIFIED ASSESS(R) PEAK FLOW METERBZH1990-08-10
381682035280322K895849RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEMBYT1989-12-22
2166662035280322K895849RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEMBYT1989-12-22
381681433415011K894361LIFECARE PRESSURE ALARM CAT. NO. 34-010CAP1989-10-05
381681704123537K883825MODIFIED SANDERS BI-PAPEASYBYE1988-12-08
2166661669559768K870962GESCO ASPIRATORBSY1987-05-22
381681515004143K870514THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERBWF1987-03-31
381741515004143K870514THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERBWF1987-03-31
381681671481864K842876PORTABLE LIFECARE VENTILATOR PLV-102CBK1984-08-29
2166661671481864K842876PORTABLE LIFECARE VENTILATOR PLV-102CBK1984-08-29
2166661576428855K832467PORTABLE LIFECARE VENTILATOR PLV-100CBK1983-10-20
381681808811946K810255MEAN PRESSURE MONITORCAP1981-02-12
381681262981624K243394AF531 Oro-Nasal SE Face MaskCBK2024-12-30
381681646374431K233555AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face MaskBZD2024-07-31
381681599104426K210844DreamWear Silicone Pillows MaskBZD2021-08-24
3186421599104426K210844DreamWear Silicone Pillows MaskBZD2021-08-24
381681671503648K210386Magneto Nasal MaskBZD2021-07-12
381741671503648K210386Magneto Nasal MaskBZD2021-07-12
381681170953279K202142Sleepware G3OLZ2020-10-29
381681328835241K201439Ventilator, Non-continuous (Respirator)BZD2020-09-25
381681305965160K200480DreamStation 2 System, DreamStation 2 Advanced SystemBZD2020-07-10
929321305965160K200480DreamStation 2 System, DreamStation 2 Advanced SystemBZD2020-07-10
3138851305965160K200480DreamStation 2 System, DreamStation 2 Advanced SystemBZD2020-07-10
865321212146795K193228Hamilton-G5CBK2020-05-04
381681698326298K183226Care Orchestrator EssenceBZD2019-10-18
865321568523532K181216HAMILTON-T1, HAMILTON-C1CBK2019-08-02
381681235570543K181170Trilogy Evo UniversalCBK2019-07-18
381741235570543K181170Trilogy Evo UniversalCBK2019-07-18
381681367408439K181166Trilogy EvoCBK2019-07-18
381741367408439K181166Trilogy EvoCBK2019-07-18
3138851367408439K181166Trilogy EvoCBK2019-07-18
381681289296073K181053Care OrchestratorBZD2019-01-04
381681242992917K180608Lunoa SystemMYB2018-06-05
865321263637701K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK2019-03-19
865321345037665K162832731 Series VentilatorsCBK2017-08-02
381681322846581K152356SapphireBZD2016-01-08
381681178595097K151120Simple T Pediatric Nasal MaskBZD2016-04-15
381681571900692K150639AF541 EE Full Face MaskBZD2015-09-18
381682062472064K150638AF541 SE Full Face MaskCBK2015-09-18
381681229801452K142988Sleepware G3OLZ2015-03-16
381681961907368K142554Revolution Full Face MaskBZD2015-01-09
3186421961907368K142554Revolution Full Face MaskBZD2015-01-09
381681980527512K140980TI NASAL MASKBZD2015-02-10
381741980527512K140980TI NASAL MASKBZD2015-02-10
3138851980527512K140980TI NASAL MASKBZD2015-02-10
3186421980527512K140980TI NASAL MASKBZD2015-02-10
381681509951709K140424RESPIRONICS REUSABLE HEATED TUBINGBZE2014-11-14
381681776268550K140268SIMPLE T YOUTH NASAL MASKBZD2014-10-20
381741776268550K140268SIMPLE T YOUTH NASAL MASKBZD2014-10-20
381681380443118K132168BRONCHOSCOPY ELBOWBZD2013-11-20
381681143798291K131982REMSTAR AUTO A-FLEX HTBZD2013-10-18
381741143798291K131982REMSTAR AUTO A-FLEX HTBZD2013-10-18
929321143798291K131982REMSTAR AUTO A-FLEX HTBZD2013-10-18
3138851143798291K131982REMSTAR AUTO A-FLEX HTBZD2013-10-18
381681560342684K130077REMSTAR SEBZD2013-05-21
929321560342684K130077REMSTAR SEBZD2013-05-21
865321855217182K123149SERVO-I VENTILATOR SYSTEMCBK2014-06-20
381681187907010K122847KANGAROO NASAL MASKBZD2013-03-06

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
BZD892024-07-31
CBK362024-12-30
MNS192012-02-01
CAF192011-10-25
MNR172009-06-26
CAW112011-11-04
MNT92012-12-14
BTT72008-03-31
BZE62014-11-14
DQA62010-07-09
BYE61999-03-09
OLZ52020-10-29
CCK52006-01-12
GWQ52001-10-15
CAP52000-06-22
BYT51991-06-03
MHX42009-03-23
BWF41996-07-15
BZK32011-06-02
BZH31996-10-25
BZQ31996-09-17
BZG31994-10-14
MYB22018-06-05
NHJ22012-12-14
NVP22011-08-09
GWK22006-09-22
LRK22004-02-06
ILQ21991-09-27
SDT12012-12-31
BYI12005-06-17
FLL12004-04-22
NOU12004-03-16
CCL12003-03-28
MQM12001-03-19
DRX11999-11-26
BZC11997-01-22
BYG11994-04-19
BSY11987-05-22

PMN

InnoSpire Go

2017-11-02

Respironics Respiratory Drug Delivery (UK) Ltd.

200 records. Showing 1-40. Next

GUDID

200 records. Showing 1-40. Next