BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ISA™ CO2

    DI: 07350046132115 · Model: CO2 · Masimo Sweden AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ISA™ CO2
    Primary DI
    07350046132115
    Version / Model
    CO2
    Catalog Number
    989803203031
    Company Name
    Masimo Sweden AB
    Labeler DUNS
    632369067
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-02
    Public Version
    2
    Public Version Date
    2021-01-18
    Public Version Status
    Update
    Public Device Record Key
    c02de9e2-dd45-4497-a9b5-a1211301a6a7

    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
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    GMDN Terms

    Code Name
    36552 Patient monitoring system module, carbon dioxide

    Identifiers

    Type ID
    Primary 07350046132115