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    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARESCAPE B850

    DI: 00840682146142 · Model: MBC323 · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    35
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CARESCAPE B850
    Primary DI
    00840682146142
    Version / Model
    MBC323
    Catalog Number
    5805690
    Company Name
    GE Healthcare Finland Oy
    Labeler DUNS
    401966697
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-13
    Public Version
    1
    Public Version Date
    2022-05-23
    Public Version Status
    New
    Public Device Record Key
    763b1c8a-5538-4a8a-bb4a-f516228d7680

    Device Description

    CARESCAPE B850 MBC323 (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
    CBR ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
    MUD Oximeter, tissue saturation
    CBS ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
    BZK Spirometer, monitoring (w/wo alarm)
    NHQ Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)
    DSJ Alarm, blood-pressure
    DQA Oximeter
    DXG COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
    KOI STIMULATOR, NERVE, PERIPHERAL, ELECTRIC
    NHO Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
    DXN System, measurement, blood-pressure, non-invasive
    MLD MONITOR, ST SEGMENT WITH ALARM
    DSI DETECTOR AND ALARM, ARRHYTHMIA
    BZQ Monitor, breathing frequency
    CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
    KRB PROBE, THERMODILUTION
    QEM Cerebral oximeter
    DQK Computer, diagnostic, programmable
    DPS Electrocardiograph
    ORT Burst suppression detection software for electroencephalograph
    OLW Index-generating electroencephalograph software
    CCL ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
    CAP MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
    BZL COMPUTER, OXYGEN-UPTAKE
    DSK COMPUTER, BLOOD-PRESSURE
    GWQ Full-montage Standard Electroencephalograph
    FLL Thermometer, electronic, clinical
    MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
    NHP Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
    DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
    OMC Reduced- montage standard electroencephalograph
    CBQ ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
    OLT Non-normalizing quantitative electroencephalograph software
    DPZ Oximeter, ear
    GWJ STIMULATOR, AUDITORY, EVOKED RESPONSE

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 00840682146142

    Premarket Submissions

    Submission Number Supplement Number
    K213336 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Humidity
    Temperature Range
    15 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    50 – 106 KiloPascal
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius