BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    Philips Medical Systems Ltda

    Reg #: 3014541700 · FEI: 3014541700 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    170
    Establishment Types
    1
    Classifications
    32

    Registration Details

    Registration Name
    Philips Medical Systems Ltda
    Registration Number
    3014541700
    FEI Number
    3014541700
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Avenida Otto Selgado, 250
    City
    Varginha Minas Gerais
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K062455

    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

    US Agent

    Business Name
    PHILIPS
    Contact Name
    Deborah Currlin
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02140
    Country
    US
    Email
    [email protected]
    Phone
    858 9452753

    Products

    Device Name Product Code
    Oximeter DQA
    Bilirubin (Total And Unbound) In The Neonate Test System MQM
    Recorder, Paper Chart DSF
    Connector, Airway (Extension) BZA
    Tape And Bandage, Adhesive KGX
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Alarm, Blood-Pressure DSJ
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Computer, Blood-Pressure DSK
    System, Network And Communication, Physiological Monitors MSX
    Continuous Measurement Thermometer FLL
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Breathing Frequency BZQ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Electrocardiograph DPS
    Monitor, St Segment With Alarm MLD
    Blood Pressure Cuff DXQ
    Detector And Alarm, Arrhythmia DSI
    System, Monitoring, Perinatal HGM
    Transducer, Gas Flow BXP
    Oximeter, Ear DPZ
    Antimicrobial Blood Pressure Cuff OED
    Transducer, Blood-Pressure, Extravascular DRS
    Monitor, Uterine Contraction, External (For Use In Clinic) HFM
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Transducer, Ultrasonic, Obstetric HGL
    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic JOM
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Transducer, Pressure, Intrauterine HFN
    Spirometer, Monitoring (W/Wo Alarm) BZK

    Proprietary Names

    Reusable SpO2 Sensor B800-500 BiliCal; 50 Pack 1037632 Bilichek (Advanced) 40477A Chemical/Thermal Paper M3708A Chemical/Thermal Paper M4816A Thermal Paper M2485A Chemical/Thermal Paper 989803190381 Efficia 50mm Chemical Thermal Paper, No Gridlines M4817A Thermal Paper 989803185271 Thermal Roll Paper, 110 mm Wide 989803138171 Defibrillator Chemical/Thermal Paper M3707A Chemical/Thermal Paper M2481A Chemical/Thermal Paper M1710A Chemical/Thermal Paper M2483A Chemical/Thermal Paper 40457C Chemical/Thermal Paper 989803138181 Defibrillator Chemical/Thermal Paper Disposable Adult / Pediatric SpO2 Sensor (M1131A) 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 B800-11 BilEclipse, 50 Pack 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 M1134A Adhesive-free Neo/Inf/Adult SpO2 Sensor Neonatal / Infant / Adult Disposable SpO2 Sensor (M1133A) Infant Disposable SpO2 Sensor (M1132A) IntelliVue Patient Monitor 6500 IntelliVue Patient Monitor 6100 IntelliVue Patient Monitor 6300 989803205391 Philips Nasal Alar SpO2 Sensor 989803205381 Philips Nasal Alar SpO2 Sensor 989803205401 Philips Nasal Alar SpO2 Sensor SpO2 Sensor M1872S Neonatal Soft Single-Patient Cuff Size#4 989803167551 Neonatal Soft Single-Patient NIBP Cuffs M1868S Neonatal Soft Single-Patient Cuff Size#2 M1866S Neonatal Soft Single-Patient Cuff Size#1 M1872B Neonatal Single-Patient Cuff Size #4 M1873S Infant Soft Single-Patient Cuff Size #5 M1866B Neonatal Single-Patient Cuff Size #1 989803167541 Neonatal Single-Patient NIBP Cuffs M1868B Neonatal Single-Patient Cuff Size #2 M1870S Neonatal Soft Single-Patient Cuff Size#3 M1873B Infant Single-Patient Cuff Size #5 M1870B Neonatal Single-Patient Cuff Size #3 Patient Monitor Capnostat 5 Mainstream CO2 Sensor for Mindray Medical Capnostat 5 Mainstream CO2 Sensor for Goldway Medical Capnostat 5 Mainstream CO2 Sensor Capnography Sensor, Reusable M4602A Reusable Abdominal Belt- 60mm Wd,1.3M Lg M4603A Reusable Abdominal Belt- 60mm Wd, 15M LG M4601A Reusable Leg Belt- 32mm X 15M M2208A Disposable abdominal belts,100/cs M1562B Reusable abdominal/leg belt- 50mm X 1.3M 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 989803183311 Multi Care Cuff, Infant 989803183361Multi Care Cuff, Large Adult 989803183351 Multi Care Cuff, Adult XL 989803183321 Multi Care Cuff, Pediatric 989803183371 Multi Care Cuff, Thigh 989803183331 Multi Care Cuff, Small Adult 989803183341 Multi Care Cuff, Adult M1572A Comfort Care Cuff, Pediatric M1573A Comfort Care Cuff, Small Adult M1575A Comfort Care Cuff, Large Adult M1574A Comfort Care Cuff, Adult M1571A Comfort Care Cuff, Infant M1576A Comfort Care Cuff, Thigh M1574XL Comfort Care Cuff, Adult XL Reusable Adult/Pediatric Ear Clip SpO2 Sensor (1.5m) (M1194A) Sp02 8-pin D-sub Adapter cbl (8pin) Oxi (M1943NL) Reusable Pediatric/Small/Adult Finger SpO2 Sensor (M1192A) Reusable Neonatal Hand/Foot SpO2 Sensor (1.5m) (M1193A) M4555B Easy Care Cuff Adult M4576B Gentle Care Cuff, Adult XL M4578B Gentle Care Cuff, Large Adult XL 989803182291 Single Care Cuff, Small Adult 989803182301 Single Care Cuff, Adult 989803182311 Single Care Cuff, Adult XL 989803182321 Single Care Cuff, Large Adult 989803182281 Single Care Cuff, Pediatric M4558B Easy Care Cuff Lrg Adult XL M4557B Easy Care Cuff Lrg Adult M4552B Easy Care Cuff, 1 Hose, Infant (1) M4553B Easy Care Cuff, 1 Hose, Pediatric (1) M4574B Gentle Care Cuff Small Adult M4573B Gentle Care Cuff Pediatric M4556B Easy Care Cuff Adult XL M4577B Gentle Care Cuff Large Adult M4554B Easy Care Cuff Sm Adult M4572B Gentle Care Cuff Infant M4559B Easy Care Cuff Thigh M4575B Gentle Care Cuff Adult Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Avalon Fetal & Maternal Patch Avalon Patient Module (M2738A) Avalon CL Fetal & Maternal Pod (866488) M1911A Fetal Monitoring Recording Paper Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA) Avalon Basestation (866074) Remote Event Marker (989803143411) 989803184851- Avalon Belt Clip M1910A Fetal Monitoring Recording Paper M2734B MECG Adapter Cable (M1363A) M1913J Fetal Monitoring Recording Paper M1913A Fetal Monitoring Recording Paper FloTrak Elite Module wI Capnostat 5 C02 Sensor SpO2 Reusable Clip Sensor Reusable SpO2 Sensor (M1196A and M1196T)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility