BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RESPIRONICS NOVAMETRIX, LLC

    Reg #: 1219324 · FEI: 1219324 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    157
    Establishment Types
    1
    Classifications
    17

    Registration Details

    Registration Name
    RESPIRONICS NOVAMETRIX, LLC
    Registration Number
    1219324
    FEI Number
    1219324
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3000 Minuteman Rd.
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092217

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Oximeter DQA
    Ventilator, Continuous, Facility Use CBK
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Connector, Airway (Extension) BZA
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Transducer, Gas Flow BXP
    Plethysmograph, Impedance DSB
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Detector And Alarm, Arrhythmia DSI
    Computer, Diagnostic, Programmable DQK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Full-Montage Standard Electroencephalograph GWQ
    Electrocardiograph DPS
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    FloTrak Elite Module wI Capnostat 5 C02 Sensor Capnostat 5 Mainstream CO2 Sensor for Mindray Medical Capnostat 5 Mainstream CO2 Sensor for Goldway Medical Capnostat 5 Mainstream CO2 Sensor Capnography Sensor, Reusable Carescape CO2 - LoFlo Respironics LoFlo Sidestream CO2 Module for Goldway Respironics LoFlo Sidestream CO2 Module Respironics LoFlo Sidestream CO2 Module for GE Respironics Alice, LoFlo, C5 Sidestream Module LoFlo Module - RoHS - Private Label C5 LoFlo Sidestream Module LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL Cobranded LoFlo CO2 Sampling Cannula LoFlo CO2 Sampling Cannula ADULT NASAL LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL LoFlo CO2 Sampling Cannula PEDIATRIC NASAL Sample Line-Female Luer Connector Cobranded LoFlo Sampling Line Kit Cobranded LoFlo Sampling Line Kit w/Dehumidification Tubing LoFlo SAMPLING LINE KIT LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL LoFlo Airway Adapter Kit ADULT/PEDIATRIC LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL LoFlo Airway Adapter Kit INFANT/NEONATAL LoFlo SAMPLING LINE KIT w/Dehumidification Tubing LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL CAPNOSTAT 5 Mainstream CO2 sensor IntelliVue Patient Monitors Philips INF Nasal CO2 O2 Cannula Philips Sample Line Kit, M2776A Philips PED INF A ADPTR W HUMID, M2773A Philips ADU Oral Nasal CO2 Can, M2756A Philips ADU Nasal CO2 Cannula, M2744A Philips PED Nasal CO2 O2 Cannula, M2751A Philips ADU Nasal CO2 O2 Cannula, M2750A Philips ADU PED A ADPTR W Humid, M2772A Philips ADU Oral Nas CO2 O2 Can, M2760A Philips PED Oral Nasal CO2 Can, M2757A Philips PED INF Airway Adapter Philips PED Oral Nas CO2 O2 Can, M2761A Philips ADU PED Airway Adapter, M2768A CO2 Nasal Cannula - Infant Philips Sample Line W HUMID Kit, M2777A CO2 Nasal Cannula - Pediatric 15mm Male/Female Adapter CapnoTrak Airway Adapter Set Reusable Neonatal CO2 Airway Adapter Neonatal Airway Adapter Pediatric/Adult Airway Adapter NOVA DISP AIRW ADPTRADLT 20/C Neonatal/Pediatric Airway Adapter Reusable Airway Adapter MaInstream CO2 Adult Pediatric/Adult Airway Adapter with Mouthpiece 15mm Male/Female Adapter Low Deadspace AA &TRAY ASSY, ADU, ZOLL MED 8000-0262 Adapter ADU Reuse Capnostat 704-0002-00 Neonatal and Pediatric CO2 Airway Adapter, Disposable Infant Airway Adapter, Disposable Zoll Neonatal Reusable Adapter, Qty 1 Pediatric and Adult CO2 Airway Adapter, Disposable AirwayAdapter PED/INF Nafion 704-0026-00 CannulaNasal/Oral CO2/O2 ADU 704-0020-00 Cannula Nasal/Oral CO2 ADU 704-0017-00 AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10 Sample Line Male Luer 704-0027-00 Cannula Nasal CO2 PED 704-0012-00 Cannula Nasal CO2 Adult 7040010-00 Cannula Nasal CO2/O2 INF 704-0015-00 Cannula Nasal CO2/O2 ADU 704-0014-00 Cannula Nasal CO2/O2 PED 704-0016-00 Airway Adapter Kit PED/INF 704-0024-00 Airway, ADU-PED, SLM LoFlo, 10 CannulaNasal/Oral CO2/O2 PED 704-0022-00 Sample Line Male Luer Nafion 704-0028-00 Pediatric / Adult Combined CO2/Flow Sensor Series 3 CO2/Flow Sensor Neonatal Neonatal Flow Sensor Series 3 Pediatric/Adult Flow Sensor Series 3 Standard Size NICO Sensor Small Size NICO Sensor Pediatric Combined CO2/Flow Sensor Series 3 Neonatal Combined CO2/Flow Sensor Series 3 CO2/Flow Sensor Adult Large Size NICO Sensor CO2/Flow Sensor Pediatric Airway Adapter Pediatric/Infant Nafion Capnoflex Pediatric Nasal/Oral CO2 Cannula Capnoflex Adult Nasal/Oral CO2 Cannula Capnoflex Pediatric Nasal CO2/O2 Cannula Capnoflex Infant/Neonatal Airway Adapter Kit Capnoflex Infant Nasal CO2 Cannula Capnoflex Cannula Nasal CO2 Only Pediatric Capnoflex Cannula Nasal CO2 Adult Capnoflex Sampling Line Male Luer-lok Adapter Dehumidification Airway Adapter Adult/Pediatric Capnoflex Cannula Nasal CO2/O2 Adult Capnoflex Airway Adapter Adult/Pediatric Nafion Capnoflex Sample Line Male Luer Capnoflex Infant Nasal CO2/O2 Cannula Cannula Oral/Nasal CO2/O2 Adult Capnoflex D ADULT AIRWAY ADAPTER, QTY 1, MAQUET Reusable Adult/Pediatric Airway Adapter Airway Adapter - Single Patient Use - Adult/Pediatric Airway Adapter - Single Patient Use - Neonatal M3014A Capnography Extension IntelliVue Patient Monitor Reusable NEO Airway Adapter, Philips Single-Patient Use Adult Airway Adapter Mainstream CO2 Sensor Reusable ADU-PED Airway Adapter, Philips NM3 Respiratory Profile Monitor Airway, DEHUM TBG, ADU PED Zoll LoFlo 10 Cannula, CO2 ORAL, ADU, Zoll LoFlo, 10 Airway, DEHUM TBG, PED INF Zoll LoFlo10 Cannula, CO2, INF, Zoll LoFlo, 10 Cannula, O2 CO2, INF, 10, Zoll LoFlo Cannula, O2 CO2 ORAL, PED, Zoll LoFlo 10 Airway, Adult Pediatric, Zoll LoFlo, 10 Airway, Pediatric Infant, Zoll LoFlo, 10 Cannula, CO2 Oral, PED, Zoll LoFlo, 10 Cannula, CO2, ADU, Zoll LoFlo, 10 Cannula, O2 CO2, PED, Zoll LoFlo, 10 Cannula, CO2, PED, Zoll LoFlo, 10 Cannula, O2 CO2, ADU, Zoll LoFlo, 10 Cannula, 02 CO2 Oral, ADU, Zoll LoFlo 10 CAPNOSTAT 5 Mainstream Sensor, Maquet CapnoTrak CO2/O2 Nasal Cannula CapnoTrak CO2 Oral Nasal Cannula CapnoTrak O2 Delivery Extension Line CapnoTrak CO2 Sampling Extension Line CapnoTrak Dehumidification Tubing CapnoTrak CO2 Nasal Cannula SAMPLING LINE MALE LUER-LOK ADAPTER DEH CapnoTrak Water Filter Assembly CapnoTrak CO2/O2 Oral Nasal Cannula Dehumidification Tubing - 1 ft. Pediatric and Adult CO2 Airway Adapter, Reusable Neonatal and Pediatric CO2 Airway Adapter, Reusable Neonatal Flow and CO2 Sensor, Disposable Proximal Flow Sensor, Neonatal Philips NM3 Respiratory Monitor w/VentAssist

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility