BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gastrostomy Tube, 3 port, 16FR, NON-ENFit

    DI: 00616784512013 · Model: 5120 · DYNAREX CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gastrostomy Tube, 3 port, 16FR, NON-ENFit
    Primary DI
    00616784512013
    Version / Model
    5120
    Company Name
    DYNAREX CORPORATION
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-01
    Public Version
    3
    Public Version Date
    2020-12-25
    Public Version Status
    Update
    Public Device Record Key
    3ac9b98b-f0ae-4d01-95a1-6a2602ecad9a

    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
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNT Tubes, Gastrointestinal (And Accessories)
    FPD Tube, Feeding

    GMDN Terms

    Code Name
    35419 Gastrostomy tube

    Identifiers

    Type ID
    Primary 00616784512013
    Package 00616784512037
    Package 00616784512044