BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DDU-100 Lifeline AED with RX activation form

    DI: 00815098020737 · Model: DCF-A100RX-EN · DEFIBTECH, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DDU-100 Lifeline AED with RX activation form
    Primary DI
    00815098020737
    Version / Model
    DCF-A100RX-EN
    Company Name
    DEFIBTECH, L.L.C.
    Labeler DUNS
    128340200
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-30
    Public Version
    1
    Public Version Date
    2021-08-09
    Public Version Status
    New
    Public Device Record Key
    dc13c8f2-314d-443d-baed-42a62b4e74d1

    Device Description

    DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year battery pack with 9V Lithium battery (DCF-200), prescription activation form

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MKJ Automated External Defibrillators (Non-Wearable)

    GMDN Terms

    Code Name
    47910 Non-rechargeable public semi-automated external defibrillator

    Identifiers

    Type ID
    Primary 00815098020737