HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
PEGASUS RESEARCH CORP.
PEGASUS RESEARCH CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2026969 | 2026969 | PEGASUS RESEARCH CORP. | 1 | Y | 2020-04-25 | 1518 E Edinger Ave Ste A Santa Ana CA US 92705 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 34707 | 1686489608 | K962534 | THERA-MIST NEBULIZER MODEL-P3000 | CAF | 1997-02-28 |
| 34707 | 1681222682 | K894000 | THERA-MIST HUMIDIFIER | BTT | 1989-08-28 |
| 34707 | 1870679357 | K893942 | THERA-MIST(TM) NEBULIZER, MODEL 30000 | CAF | 1989-08-28 |
| 34707 | 1464575918 | K880473 | AERO-MIST NEBULIZER HEATER | CAF | 1988-03-31 |
| 34707 | 1368255827 | K122857 | HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 | CAF | 2012-11-07 |
| 34707 | 1184732779 |
Product Codes Associated With Registrations#
PMN#
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
PEGASUS RESEARCH CORP.
PMH 1000 HEATED HUMIDIFIER
PEGASUS RESEARCH CORP.
HEATED HUMIDIFIER
PEGASUS RESEARCH CORP.
THERA-MIST NEBULIZER MODEL-P3000
PEGASUS RESEARCH CORP.
AQUALARM MOISTURE SENSOR MODEL P85000
PEGASUS RESEARCH CORP.
AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED
PEGASUS RESEARCH CORP.
AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000
PEGASUS RESEARCH CORP.
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
PEGASUS RESEARCH CORP.
THERA-MIST HUMIDIFIER
PEGASUS RESEARCH CORP.
THERA-MIST(TM) NEBULIZER, MODEL 30000
PEGASUS RESEARCH CORP.
AERO-MIST NEBULIZER HEATER
PEGASUS RESEARCH CORP.
GUDID#
CURAPLEX - NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER
2016-09-23
PEGASUS - NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER
2016-09-23
THERMAGARD - NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER
2016-09-23
CURAPLEX - NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER, AIRLIFE FIT
2021-09-15
PEGASUS - FLO2 STANDARD FLOW OXYGEN DILUTER, PEDIATRIC KIT
2021-09-17
PEGASUS - FLO2 STANDARD FLOW OXYGEN DILUTER
2021-09-17
PEGASUS - FLO2 STANDARD FLOW OXYGEN DILUTER, ADULT KIT
2021-09-17
PEGASUS - FLO2 HIGH FLOW OXYGEN DILUTER, PEDIATRIC KIT
2021-09-17
PEGASUS - FLO2 HIGH FLOW OXYGEN DILUTER
2021-09-17
PEGASUS - FLO2 HIGH FLOW OXYGEN DILUTER, ADULT KIT
2021-09-17
CURAPLEX - CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM
2016-09-24
MISTIC - CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM
2016-09-24
CURAPLEX RES-Q - CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM, WITH ADULT MASK
2016-09-23
MISTIC - ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, AIRLIFE FIT
2016-09-23
CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, PACKAGED WITH 500ML BOTTLE
2016-09-24
MISTIC - ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM
2016-09-23
CURAPLEX - ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM AND 500ML BOTTLE COMBINATION
2021-09-15
MISTIC - NEBULIZER,BARREL REUSABLE BOTTLE 1000ML
2021-09-17
CURAPLEX RES-Q - CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM, WITH PEDIATRIC MASK
2016-09-23
CURAPLEX - CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM, LONG TUBE
2016-09-24
CURAPLEX RES-Q - CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM
2016-09-23
RES-Q - CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM
2016-09-23
CURAPLEX - CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
2016-09-23
MISTIC - CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
2016-09-23
MISTIC - ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, AIRLIFE FIT
2016-09-23
CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, SHORT TUBE, UP TO 40 LPM
2016-09-24
CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, LONG TUBE, UP TO 40 LPM
2016-09-24
CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM
2016-09-23
CURAPLEX - ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, SHORT TUBE
2016-09-23
CURAPLEX - ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, LONG TUBE
2016-09-23
CURAPLEX - ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
2016-09-23
MISTIC - ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM
2016-09-23
CURAPLEX - CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, WITH 500ML BOTTLE COMBINATION
2021-09-15
CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, WITH 500ML BOTTLE COMBINATION
2021-09-15
CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, SHORT TUBE, UP TO 40 LPM, AIRLIFE FIT
2021-09-15
CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, LONG TUBE, UP TO 40 LPM, AIRLIFE FIT
2021-09-15
CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, AIRLIFE FIT
2021-09-15
MISTIC - ENTRAINMENT NEBULIZER WITH GASKET, HIGH FLOW, UP TO 40 LPM, SAP CANADA,
2016-09-23
CURAPLEX - ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, SHORT TUBE, AIRLIFE FIT
2021-09-15
CURAPLEX - ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, LONG TUBE, AIRLIFE FIT
2021-09-15