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    FDA UDI In Commercial Distribution 🇺🇸 United States

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    DI: 00840682104425 · Model: 2040427-003 · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    33
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00840682104425
    Version / Model
    2040427-003
    Company Name
    GE Healthcare Finland Oy
    Labeler DUNS
    401966697
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-22
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    7780863e-4e88-4c51-8a22-3fb345e1a696

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 00840682104425

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K131414 000

    Storage Conditions

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