BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    IntelliVue Patient Monitor

    Reg #: 3009077524 · FEI: 3009077524 · Expires 2025
    View on FDA
    Products
    39
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    39

    Registration Details

    Registration Name
    DHL SUPPLY CHAIN (NETHERLANDS) B.V.
    Registration Number
    3009077524
    FEI Number
    3009077524
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zwenkgras 9
    City
    Beringe Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K150310

    Owner / Operator

    Firm Name
    DHL Supply Chain (Netherlands) B.V.
    Operator Number
    10085309
    Address
    Zwenkgras 15
    City
    Beringe
    State
    Noord-Brabant
    Postal Code
    5986 PM
    Country
    NL
    Correspondent
    QHSE Beringe

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Adaptor, Lead Switching, Electrocardiograph DRW
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    System, Signal Isolation DRJ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Calculator, Pulmonary Function Data BZC
    Detector And Alarm, Arrhythmia DSI
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Burst Suppression Detection Software For Electroencephalograph ORT
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Recorder, Paper Chart DSF
    Electrocardiograph DPS
    System, Network And Communication, Physiological Monitors MSX
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Transducer, Blood-Pressure, Extravascular DRS
    Probe, Thermodilution KRB
    Tester, Electrode, Surface, Electrocardiographic KRC
    Computer, Blood-Pressure DSK
    Analyzer, Spectrum, Electroencephalogram Signal GWS
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Stimulator, Nerve, Peripheral, Electric KOI
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    System, Balloon, Intra-Aortic And Control DSP
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, St Segment MLC
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Monitor, Breathing Frequency BZQ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Continuous Measurement Thermometer FLL
    Oximeter DQA
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Alarm, Blood-Pressure DSJ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Recorder, Magnetic Tape, Medical DSH

    Proprietary Names

    IntelliVue Patient Monitor

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device