BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ADVANCED MONITOR DEFIBRILLATOR

    DI: B510D100 · Model: D100+ · ADVANCED INSTRUMENTATIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ADVANCED MONITOR DEFIBRILLATOR
    Primary DI
    B510D100
    Version / Model
    D100+
    Company Name
    ADVANCED INSTRUMENTATIONS, INC.
    Labeler DUNS
    608736880
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-14
    Public Version
    1
    Public Version Date
    2026-01-22
    Public Version Status
    New
    Public Device Record Key
    a08a9f8f-fdc3-4f55-a52c-5984d7f73baa

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

    GMDN Terms

    Code Name
    46990 Troponin T IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary B510D100