BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARESCAPE

    DI: 00840682105118 · Model: Monitor B850 CPU-C1 · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    33
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CARESCAPE
    Primary DI
    00840682105118
    Version / Model
    Monitor B850 CPU-C1
    Company Name
    GE Healthcare Finland Oy
    Labeler DUNS
    401966697
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-03
    Public Version
    6
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    bf4d18b8-3cc9-4511-816c-308aa2e159c8

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

    GMDN Terms

    Code Name
    33586 General-purpose multi-parameter bedside monitor

    Identifiers

    Type ID
    Primary 00840682105118

    Customer Contacts

    Phone
    +1(800)558-5120
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K131414 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    10 – 35 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    50 – 106 KiloPascal
    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
    15 – 90 Percent (%) Relative Humidity