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    CARESCAPE Canvas D19

    DI: 00195278523365 · Model: 5897061 · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    34
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CARESCAPE Canvas D19
    Primary DI
    00195278523365
    Version / Model
    5897061
    Catalog Number
    5897061
    Company Name
    GE Healthcare Finland Oy
    Labeler DUNS
    401966697
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-19
    Public Version
    1
    Public Version Date
    2023-04-27
    Public Version Status
    New
    Public Device Record Key
    4f2fabfa-89e1-46be-9dca-a307789e2d44

    Device Description

    CARESCAPE Canvas D19

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

    GMDN Terms

    Code Name
    36612 Image display unit, colour

    Identifiers

    Type ID
    Primary 00195278523365

    Premarket Submissions

    Submission Number Supplement Number
    K223531 000

    Storage Conditions

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