BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Patient Monitor

    DI: 06944413815896 · Model: iX12 · Edan Instruments, Inc.
    View on AccessGUDID
    Product Codes
    18
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Patient Monitor
    Primary DI
    06944413815896
    Version / Model
    iX12
    Company Name
    Edan Instruments, Inc.
    Labeler DUNS
    529173163
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-17
    Public Version
    2
    Public Version Date
    2025-03-24
    Public Version Status
    Update
    Public Device Record Key
    7920c633-bc47-44a0-8d25-0cb38c65ad51

    Device Characteristics

    Single Use
    No
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    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)
    DSK Computer, Blood-Pressure
    NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
    CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
    DPS Electrocardiograph
    NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
    DSI Detector And Alarm, Arrhythmia
    MLD Monitor, St Segment With Alarm
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
    DXN System, Measurement, Blood-Pressure, Non-Invasive
    FLL Thermometer, Electronic, Clinical
    DQA Oximeter
    CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
    CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
    BZQ Monitor, Breathing Frequency
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase
    NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 06944413815896