BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARESCAPE Software

    DI: 00840682147811 · Model: 3.2 · GE Healthcare Finland Oy
    View on AccessGUDID
    Product Codes
    35
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CARESCAPE Software
    Primary DI
    00840682147811
    Version / Model
    3.2
    Catalog Number
    NA
    Company Name
    GE Healthcare Finland Oy
    Labeler DUNS
    401966697
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-15
    Public Version
    1
    Public Version Date
    2026-04-23
    Public Version Status
    New
    Public Device Record Key
    9cd122b9-4cc3-4df1-8387-6d368f81512d

    Device Description

    SOFTWARE V3.2

    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
    Labeling does not contain MRI Safety Information
    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
    BZL Computer, Oxygen-Uptake
    BZK Spirometer, Monitoring (W/Wo Alarm)
    BZQ Monitor, Breathing Frequency
    DSI Detector And Alarm, Arrhythmia
    GWJ Stimulator, Auditory, Evoked Response
    KRB Probe, Thermodilution
    OLW Index-Generating Electroencephalograph Software
    CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
    OMC Reduced- Montage Standard Electroencephalograph
    DSK Computer, Blood-Pressure
    FLL Continuous Measurement Thermometer
    NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
    CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
    DXN System, Measurement, Blood-Pressure, Non-Invasive
    CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
    CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
    GWQ Full-Montage Standard Electroencephalograph
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
    DQK Computer, Diagnostic, Programmable
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
    QEM Cerebral Oximeter
    MLD Monitor, St Segment With Alarm
    DSJ Alarm, Blood-Pressure
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
    ORT Burst Suppression Detection Software For Electroencephalograph
    KOI Stimulator, Nerve, Peripheral, Electric
    OLT Non-Normalizing Quantitative Electroencephalograph Software
    DPS Electrocardiograph
    DPZ Oximeter, Ear
    DQA Oximeter
    NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function
    MUD Oximeter, Tissue Saturation

    GMDN Terms

    Code Name
    66625 Physiologic monitor-installed software

    Identifiers

    Type ID
    Primary 00840682147811

    Premarket Submissions

    Submission Number Supplement Number
    K213181 000
    K213336 000
    K213363 000