BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Spirometry Sensor

    DI: 20884838072248 · Model: Flow Sensor Neonatal · Philips Medizin Systeme Böblingen GmbH
    View on AccessGUDID
    Product Codes
    39
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Spirometry Sensor
    Primary DI
    20884838072248
    Version / Model
    Flow Sensor Neonatal
    Catalog Number
    989803144671
    Company Name
    Philips Medizin Systeme Böblingen GmbH
    Labeler DUNS
    314101143
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2017-01-20
    Public Version
    9
    Public Version Date
    2023-05-05
    Public Version Status
    Update
    Public Device Record Key
    f3c6efd0-9159-412f-bfb2-bf5d76021614

    Device Description

    The M2786A in combination with the spirometry module M1014A is designed to allow measurement of airway pressures, flow, minute volume, tidal volume, airway compliance, airway resistance and CO2.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    35353 Monitoring spirometer, electrical

    Identifiers

    Type ID
    Primary 20884838072248
    Unit of Use 00884838072244

    Customer Contacts

    Phone
    +1(999)999-9999
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 70 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 158 Degrees Fahrenheit
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    53.3 – 106.7 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity