BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AVANTGARDE

    DI: 05060182171894 · Model: AVG100+T · PROSYS INTERNATIONAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    AVANTGARDE
    Primary DI
    05060182171894
    Version / Model
    AVG100+T
    Company Name
    PROSYS INTERNATIONAL LIMITED
    Labeler DUNS
    221836112
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2023-10-20
    Public Version
    1
    Public Version Date
    2023-10-30
    Public Version Status
    New
    Public Device Record Key
    71ecf931-3919-4b88-bad5-6dc55eca3e1b

    Device Description

    Fecal Management System

    Device Characteristics

    Single Use
    Yes
    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 Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNT Tubes, Gastrointestinal (And Accessories)

    GMDN Terms

    Code Name
    47039 Faecal incontinence kit

    Identifiers

    Type ID
    Unit of Use 15060182171891
    Primary 05060182171894

    Premarket Submissions

    Submission Number Supplement Number
    K193325 000