BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RESPIRONICS INC.

    Reg #: 2518422 · FEI: 2518422 · Expires 2026
    View on FDA
    Products
    43
    Proprietary Names
    258
    Establishment Types
    5
    Classifications
    43

    Registration Details

    Registration Name
    RESPIRONICS INC.
    Registration Number
    2518422
    FEI Number
    2518422
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1001 Murry Ridge Lane
    City
    MURRYSVILLE
    State
    PA
    ZIP
    15668
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121623

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2518422
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Sv70 Ventilator MNT
    Ventilator, Continuous, Non-Life-Supporting MNS
    Spirometer, Diagnostic BZG
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Ventilator, Non-Continuous (Respirator) BZD
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Spirometer, Therapeutic (Incentive) BWF
    Pillow, Cervical (For Mild Sleep Apnea) MYB
    Ventilatory Effort Recorder MNR
    Oximeter DQA
    Airway, Oropharyngeal, Anesthesiology CAE
    Device, Biofeedback HCC
    Full-Montage Standard Electroencephalograph GWQ
    Ventilator, Continuous, Facility Use CBK
    Stand, Infusion FOX
    Monitor, Breathing Frequency BZQ
    Strap, Head, Gas Mask BTK
    Continuous, Ventilator, Home Use NOU
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Medical Device Data System OUG
    Calculator, Pulmonary Function Data BZC
    Nebulizer (Direct Patient Interface) CAF
    Device, Positive Pressure Breathing, Intermittent NHJ
    Mask, Oxygen BYG
    Meter, Peak Flow, Spirometry BZH
    Ventilator, External Body, Negative Pressure, Adult (Cuirass) BYT
    Continuous Measurement Thermometer FLL
    Generator, Oxygen, Portable CAW
    Holding Chambers, Direct Patient Interface NVP
    Device, Anti-Snoring LRK
    Tubing, Pressure And Accessories BYX
    Compressor, Air, Portable BTI
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Electrode, Electrocardiograph DRX
    Drain, Tee (Water Trap) BYH
    Intra-Pulmonary Percussive Vibration (Ipv) Devices SDT
    Standard Polysomnograph With Electroencephalograph OLV
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Mouthpiece, Breathing BYP
    Protector, Skin Pressure FMP
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI

    Proprietary Names

    DirectView Data Management System Encore Anywhere A40 Heated Humidifier OMNILAB DIRECT Universal Battery Pack (UBP2) BiPAP A40 Ventilatory Support System PC Direct Omnilab Direct Omnilab Advanced/Advanced + BiPAP autoSV Advanced System One BiPAP w/ & w/o Humidifier DreamStation BiPAP autoSV w/ & w/o Humidifier DreamStation BiPAP S/T w/ & w/o Humidifier DreamStation BiPAP AVAPS w/ & w/o Humidifier AF531 FFM AF541 FFM AF421 FFM Quantum Respiratory Effort Sensor Heated Humidifier - HC500 Cannula Style Thermocouples Performance Tubing 6' DreamStation BiPAP Auto w/ & w/o Humidifier Dreamstation CPAP Auto w/ & w/o Humidifier REMstar Auto A-flex HT (Q-series) DreamStation CPAP w/ & w/o Humidifier Dreamstation CPAP Pro w/ & w/o Humidifier DreamStation BiPAP Pro w/ & w/o Humidifier DreamStation Go CPAP DreamStation Go Auto CPAP Dreamstation GO w/ & w/o Humidifier DreamStation CPAP Assist BiliChek Threshold Pep NightBalance Dreamstation 2 Advanced System Dreamstation 2 System Alice PDX Nonin Finger Oximeter Multiple - Invasive Flex Trach Adaptor 15 cm, 22M/15F-15F Flex Trach Adaptor 15 cm, 22M/15F-22F SmartSleep, Deep Sleep Headband V60 with PPV and Auto-Trak + Disposable Swivel Passive Exhalation Port Whisper Swivel II Spectrum Actiwatch Score Shimmer Full Face Mask S/M/L/MW Dreamwear Full Med Frm w/HGR BiPAP S/T ventilatory support system BiPAP AVAPS ventilatory support system Trilogy 202 Ventilator Trilogy Nurse Call Adaptor Cable Performax FitLife SE Total Face Mask Nuance and Nuance Pro Nasal Pillow Mask Trilogy Evo Roll Stand – RIMR Roll Stand, OmniLab Advanced + - RIMR DreamStation 2 Roll Stand – RIST Trilogy Evo Mounting Bracket - RIMR Trilogy Evo Wheelchair Mount – RIMR Roll Stand, BiPAP A-series – RIMR DreamStation Roll Stand - RIST SPRS-2 Roll Stand, H-111 cm, EV300 Mount REMstar SE CPAP Dorma CPAP RUSleeping Crystal Trace Piezo Sensor Bronchoscopy Elbow, Click Style Bronchoscopy elbow AF541 SE Full Face Mask Chin Strap Headgear FFM PTrak FFM Performax, FitLife EE Total Face Mask Trilogy Evo Ventilator Nurse Call Rj9 Adapter Cable Open Dual Limb Active Exhalation Valve Nurse Call Adaptor Cable – Alarm Open/Closed Trilogy EV300 12/24V Battery Cable w/terminals or adapter External Flow Sensor Assembly Adult/Pediatric OR Pediatric/Infant Performax Pediatric SE Total FFM CPAP VALVES Dreamwear Silicone Pillows Mask DreamStation Link Module (RIST) Payer Integration Software (RIMR) Omnilab Conncect (RIMR) AOM (RIMR) Sleepmapper (RIMR) DreamStation Wi-Fi Accessory (RIST) HL7 Interface Utility (RIMR) DreamStation Cellular Modem (RIST) PR1 Wired/Wireless Modems (RIST) DreamMapper FloTrak CO2 Sensor Flow Sensor Pressure Transducer Airflow Sensor (PTAF) Pro-Flow and Pro-Flow Plus Cannula Sensors PTAF 2, 3, Lite Sidestream Plus Pediatric Mask Sidestream Plus Adult Mask Sidestream Plus Nebulizer Cough Assist T70 Trilogy 100 Ventilator BT, U.S. Trilogy EC Ventilator Garbin Ventilator BT Trilogy 100 BT International Trilogy 100 Ventilator PLM Sensor ProChamber Valved Holding Chamber TrueBlue Nasal Mask Pico SE Nasal Mask Masimo MS Series Total Face Mask Heated Humidifier - HC100 AF541 EE Leak 1 Full Face Mask AF541 EE Leak 2 Full Face Mask AP111 EE/SE Nasal Mask Contour Deluxe/Comfort/Ptrak Nasal Mask SIDESTREAM TUCKER THE TURTLE MASK, SYSTEM 22 PAEDIATRIC MASK Alice NightOne Thermistor Cannula Style Personal Best Low Range Peak Flow Meter Chest Shell and components A30 Heated Humidifier BiPAP V30 Auto BiPAP A30 Ventilatory Support System REMstar Q-Series CPAP EncoreAnywhere BiPAP Q-Series PN841 Nasal Mask Wisp Pediatric Nasal Mask PN841 SE Nasal Mask Wisp Pediatric Nasal Mask SE Elbow Accessory 920 & 920M Handheld Pulse Oximeter Masimo Oximetry Kit REMStar SE CPAP Disposable/FEP/Invasive Circuits BiPAP Vision Sidestream Disposable Neb and Masks Passover Humidifier Opti Chamber Valved Holding Chamber SM Child Nasal Mask Vitalsense Bronchoscopy Elbow LiteTouch Mask Comfort Gel Blue Nasal Mask SimplyGo POC SimplyFlo POC SimplyGo Mini POC Nonin Wrist Ox REMstar Heated Humidifier Encore/Encore Pro Data Management System REMstar Plus CPAP OptiChamber Diamond with Lite Touch mask SnoreSilencer Performance Tubing Low Range Cabinet Flow Meter Oxygen Manifold Kit PLV-102 & 102b AF531 Oro-Nasal SE Face Mask Stardust 2 Stardust I, II Heated Humidifier - MR850 BiPAP AVAPS or S/T C-Series Innospire Essence Innospire Elegance Disposable 15 mm non-heated passive and heated active circuits Disposable 22mm non-heated passive and heated active circuits Disposable 15mm MPV circuit Pressure Valve Care Orchestrator Nonin Oximetry Kit ECG electrode REMstar/BiPAP Q-Series w/HT BiPAP Q-Series w/HT REMstar Q-series CPAP w/HT Drain, Tee (water trap) Respironics Disposable Heated Wire Circuits Disposable Adult/Ped Heated Active Circuit Disposable Adult/Ped Heated Passive Circuit CoughAssist Simply Clear WhisperFlow Procedure Packs Heated Humidifier - MR410 PAM-RL Threshold IMT Peak Flow Meter Asthma Check Asthma Mentor REMstar Auto w/C-Flex & Heated Humi PerforMax Pediatric EE Total FFM - Leak 1 and 2 Wisp Nasal Mask Wisp SE Nasal Mask I-neb TIM/General Purpose Adam Shell Thermocouple Assembly Amara View FFM - RIMR, RIMP ComfortFull FFM - RSZ Amara FFM - RIMR, RIMP OPI & non-OPI Millennium Transfill Millenium M10 Sleepware G3 Sleepware Alice 6 PSG Base Station LDE LDxN LDxS Alice 6 Headbox LDE LDx Alice PSG or components ECG wireset Assess Low Range Peak Flow Meter Snoring Microphone Remote Alarm AP111 Nasal Mask Optilife Nasal Mask Pro-flow multi-purpose nasal cannula Mouthpiece, Angled Disposable Angled Mouthpiece Reusable Mouthpiece Mouthpiece Straight REMstar Pro w C Flex CPAP System Wisp Youth Nasal Mask System 22 Aerosol Mask AF531 Oro-Nasal EE Leak 1 Face Mask AF531 Oro-Nasal EE Leak 2 Face Mask Care Orchestrator Essence Care Orchestrator Essence 4.3 USB Release Care Orchestrator Essence, Japan Body Position Sensor ComfortGel Blue SE FFM Amara View SE FFM LiquiCell CPAP Cushions AF811 FFM ComfortGel Blue FFM DreamWear Full Mask DreamWear Nasal Mask DreamWisp Nasal Mask Therapy Mask 3100 NC/SP Sleepware G3, Event Detection Software 920M Plus Pulse Oximeter Nonin Handheld AF531 SE Full Face Mask Trilogy Evo Universal Ventilator EZ-1 System Resp Sensor/ZRIP V60 Ventilator Patient Circuits Sidestream Reusable Neb and Masks I-Neb AAD Nebulizer w/Insight SW or Components Innospire Mini EverFlo EverFlo Quiet OPI and non-OPI Ultrafill Quiet Everflo Ultrafill Transfill Everflo/Everflo Q/L4

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Manufacture Device in the United States for Export Only