BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARESCAPE Canvas Smart Display

    DI: 00195278522313 · Model: 5897060 · 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 Smart Display
    Primary DI
    00195278522313
    Version / Model
    5897060
    Catalog Number
    5897060
    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
    07f49361-4b5f-4a55-95d4-fdd62c0f47cb

    Device Description

    CARESCAPE Canvas Smart Display

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

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 00195278522313

    Premarket Submissions

    Submission Number Supplement Number
    K223531 000

    Storage Conditions

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