BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00840682138574 · Model: B105 Patient Monitor · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    26
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00840682138574
    Version / Model
    B105 Patient Monitor
    Catalog Number
    2099000-003
    Company Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Labeler DUNS
    784985108
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-16
    Public Version
    3
    Public Version Date
    2022-04-27
    Public Version Status
    Update
    Public Device Record Key
    d40c9feb-d45c-4b40-b84f-beceea4f7101

    Device Description

    B105 V1.5 PATIENT MONITOR 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
    FLL Thermometer, electronic, clinical
    CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
    CBS ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
    KRB PROBE, THERMODILUTION
    NHQ Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)
    CCL ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
    MLD MONITOR, ST SEGMENT WITH ALARM
    DQA Oximeter
    NHO Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
    DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
    DSK COMPUTER, BLOOD-PRESSURE
    NHP Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
    DPZ Oximeter, ear
    BZQ Monitor, breathing frequency
    DSJ Alarm, blood-pressure
    DQK Computer, diagnostic, programmable
    DSI DETECTOR AND ALARM, ARRHYTHMIA
    CBQ ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
    OLW Index-generating electroencephalograph software
    GWQ Full-montage Standard Electroencephalograph
    MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
    CBR ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
    OMC Reduced- montage standard electroencephalograph
    ORT Burst suppression detection software for electroencephalograph
    OLT Non-normalizing quantitative electroencephalograph software
    DXN System, measurement, blood-pressure, non-invasive

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 00840682138574

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K201941 000

    Storage Conditions

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