BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    andorate® Disposable Endoscope Valves Set

    DI: 04897106950324 · Model: GAR037C · GA Health Company Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    andorate® Disposable Endoscope Valves Set
    Primary DI
    04897106950324
    Version / Model
    GAR037C
    Company Name
    GA Health Company Limited
    Labeler DUNS
    686908512
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-28
    Public Version
    3
    Public Version Date
    2022-04-25
    Public Version Status
    Update
    Public Device Record Key
    7123374c-5ccb-4537-b4bf-f04e8e4c6e20
    Distribution End Date
    2021-05-07

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    60760 Endoscope channel support kit

    Identifiers

    Type ID
    Package 14897106950321
    Primary 04897106950324
    Package 24897106950328