BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dupel BLUE

    DI: 00850030915047 · Model: 199334-001 · South Dakota Partners Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dupel BLUE
    Primary DI
    00850030915047
    Version / Model
    199334-001
    Company Name
    South Dakota Partners Inc.
    Labeler DUNS
    080639793
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-02
    Public Version
    1
    Public Version Date
    2023-08-10
    Public Version Status
    New
    Public Device Record Key
    8a2a9d4f-aa84-4a69-b7c0-57b5615ad00c

    Device Description

    Iontophoresis Electrode, Medium Butterfly 2.0 mL

    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
    Yes
    Has Serial Number
    No
    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
    EGJ Device, Iontophoresis, Other Uses

    GMDN Terms

    Code Name
    46304 Drug-delivery iontophoresis system electrode, active

    Identifiers

    Type ID
    Package 00850030915054
    Primary 00850030915047
    Package 00850030915061