BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00840682146715 · Model: B125 VSP3.0 Patient Monitor · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    27
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00840682146715
    Version / Model
    B125 VSP3.0 Patient Monitor
    Catalog Number
    6160000-004
    Company Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Labeler DUNS
    006580799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-12
    Public Version
    1
    Public Version Date
    2022-04-20
    Public Version Status
    New
    Public Device Record Key
    fdef048e-0676-4ce2-a003-076cf28b5a39

    Device Description

    B125M ATO MODEL

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    OMC Reduced- montage standard electroencephalograph
    CBQ ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
    DPZ Oximeter, ear
    DQK Computer, diagnostic, programmable
    MLD MONITOR, ST SEGMENT WITH ALARM
    GWQ Full-montage Standard Electroencephalograph
    MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
    OLT Non-normalizing quantitative electroencephalograph software
    NHQ Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)
    DXN System, measurement, blood-pressure, non-invasive
    CBS ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
    DSI DETECTOR AND ALARM, ARRHYTHMIA
    CCL ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
    KRB PROBE, THERMODILUTION
    NHO Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
    DSK COMPUTER, BLOOD-PRESSURE
    OLW Index-generating electroencephalograph software
    BZQ Monitor, breathing frequency
    DQA Oximeter
    ORT Burst suppression detection software for electroencephalograph
    DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
    FLL Thermometer, electronic, clinical
    KOI STIMULATOR, NERVE, PERIPHERAL, ELECTRIC
    NHP Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
    CBR ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
    DSJ Alarm, blood-pressure
    CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 00840682146715

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K213490 000

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Handling Environment Temperature
    Temperature Range
    5 – 35 Degrees Celsius