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    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARESCAPE RAD

    DI: 00840682123433 · Model: MBRA001 · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    33
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CARESCAPE RAD
    Primary DI
    00840682123433
    Version / Model
    MBRA001
    Company Name
    GE Healthcare Finland Oy
    Labeler DUNS
    401966697
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-05
    Public Version
    1
    Public Version Date
    2020-03-13
    Public Version Status
    New
    Public Device Record Key
    a0f88ef4-bc0a-4e80-b9aa-811d1e47078c

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

    GMDN Terms

    Code Name
    62911 Physiologic monitoring system alarm

    Identifiers

    Type ID
    Primary 00840682123433

    Customer Contacts

    Phone
    +1 (608) 515 3077
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K191149 000
    K191249 000
    K191323 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 Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius