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    FDA UDI In Commercial Distribution 🇺🇸 United States

    SO2 Optical Module

    DI: 00884838020849 · Model: SO2 Optical Module · Philips Medizin Systeme Böblingen GmbH
    View on AccessGUDID
    Product Codes
    39
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SO2 Optical Module
    Primary DI
    00884838020849
    Version / Model
    SO2 Optical Module
    Catalog Number
    989803151591
    Company Name
    Philips Medizin Systeme Böblingen GmbH
    Labeler DUNS
    314101143
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-12-18
    Public Version
    6
    Public Version Date
    2023-05-05
    Public Version Status
    Update
    Public Device Record Key
    bc7aea4f-c0a2-47ea-8f2e-680a2238ef7a

    Device Description

    SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular catheters such as scvO2 and svO2. See Instructions for Use for compatible catheters, catheters are not available from Philips.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DSI DETECTOR AND ALARM, ARRHYTHMIA
    CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
    LKD Monitor, Carbon-Dioxide, Cutaneous
    NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function
    NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
    DRS Transducer, Blood-Pressure, Extravascular
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)
    MLC Monitor, St Segment
    BZC Calculator, Pulmonary Function Data
    BZQ Monitor, Breathing Frequency
    DXN System, Measurement, Blood-Pressure, Non-Invasive
    DSF Recorder, Paper Chart
    KOI Stimulator, Nerve, Peripheral, Electric
    KRC Tester, Electrode, Surface, Electrocardiographic
    CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
    CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
    DSK Computer, Blood-Pressure
    NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
    MLD Monitor, St Segment With Alarm
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase
    DSJ Alarm, Blood-Pressure
    GWS Analyzer, Spectrum, Electroencephalogram Signal
    KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
    DPS Electrocardiograph
    FLL Thermometer, Electronic, Clinical
    DRQ Amplifier And Signal Conditioner, Transducer Signal
    ORT Burst Suppression Detection Software For Electroencephalograph
    KRB Probe, Thermodilution
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    DQA Oximeter
    DRJ System, Signal Isolation
    DRW Adaptor, Lead Switching, Electrocardiograph
    MSX System, Network And Communication, Physiological Monitors
    DSH Recorder, Magnetic Tape, Medical
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
    DSP System, Balloon, Intra-Aortic And Control

    GMDN Terms

    Code Name
    46299 Intravascular oxygen monitoring system

    Identifiers

    Type ID
    Primary 00884838020849

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    27 – 105 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    20 – 90 Percent (%) Relative Humidity