BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    andorate® CO2 Extend Tubing with Luer Connector

    DI: 04897106953790 · Model: GAR091 · GA Health Company Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    andorate® CO2 Extend Tubing with Luer Connector
    Primary DI
    04897106953790
    Version / Model
    GAR091
    Company Name
    GA Health Company Limited
    Labeler DUNS
    686908512
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-23
    Public Version
    3
    Public Version Date
    2023-10-16
    Public Version Status
    Update
    Public Device Record Key
    c030db06-9755-4dc2-917f-f6079d43a4fd

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FCX Insufflator, Automatic Carbon-Dioxide For Endoscope

    GMDN Terms

    Code Name
    60738 Endoscopic insufflation tubing set, single-use

    Identifiers

    Type ID
    Package 14897106953797
    Primary 04897106953790
    Package 24897106953794

    Premarket Submissions

    Submission Number Supplement Number
    K200388 000