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    CARESCAPE B650

    DI: 00840682146111 · Model: MBB323 · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    35
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CARESCAPE B650
    Primary DI
    00840682146111
    Version / Model
    MBB323
    Catalog Number
    5805688
    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
    4a894bf5-dc6c-4e86-bfd4-fe2a4521f7ef

    Device Description

    CARESCAPE B650 MBB323 (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
    QEM Cerebral oximeter
    MUD Oximeter, tissue saturation
    OLT Non-normalizing quantitative electroencephalograph software
    OMC Reduced- montage standard electroencephalograph
    CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
    GWQ Full-montage Standard Electroencephalograph
    DXG COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
    BZQ Monitor, breathing frequency
    DPZ Oximeter, ear
    NHP Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
    DPS Electrocardiograph
    DQA Oximeter
    CBR ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
    DQK Computer, diagnostic, programmable
    MLD MONITOR, ST SEGMENT WITH ALARM
    DSK COMPUTER, BLOOD-PRESSURE
    FLL Thermometer, electronic, clinical
    NHO Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
    ORT Burst suppression detection software for electroencephalograph
    BZK Spirometer, monitoring (w/wo alarm)
    DSI DETECTOR AND ALARM, ARRHYTHMIA
    CAP MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
    DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
    CBQ ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
    DXN System, measurement, blood-pressure, non-invasive
    GWJ STIMULATOR, AUDITORY, EVOKED RESPONSE
    KRB PROBE, THERMODILUTION
    DSJ Alarm, blood-pressure
    CBS ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
    OLW Index-generating electroencephalograph software
    KOI STIMULATOR, NERVE, PERIPHERAL, ELECTRIC
    CCL ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
    BZL COMPUTER, OXYGEN-UPTAKE
    MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
    NHQ Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 00840682146111

    Premarket Submissions

    Submission Number Supplement Number
    K213181 000

    Storage Conditions

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