BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    andorate® Air/Water Bottle Tubing

    DI: 04897106954957 · Model: GAR088US · GA Health Company Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    andorate® Air/Water Bottle Tubing
    Primary DI
    04897106954957
    Version / Model
    GAR088US
    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
    42f28c01-bde0-4d4c-89a4-28076aa852b5

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCX Endoscopic Irrigation/Suction System

    GMDN Terms

    Code Name
    60738 Endoscopic insufflation tubing set, single-use

    Identifiers

    Type ID
    Package 14897106954954
    Primary 04897106954957
    Package 24897106954951

    Premarket Submissions

    Submission Number Supplement Number
    K200388 000