BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Defibtech Branford

    Reg #: 3012972516 · FEI: 3012972516 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    Defibtech Branford
    Registration Number
    3012972516
    FEI Number
    3012972516
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14 Commercial St
    City
    Branford
    State
    CT
    ZIP
    06405
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141809
    PMA Number
    P160032

    Owner / Operator

    Firm Name
    DEFIBTECH, LLC
    Operator Number
    9048526
    Address
    741 BOSTON POST ROAD, SUITE 201
    City
    Guilford
    State
    CT
    Postal Code
    06437
    Country
    US
    Correspondent
    Robert Jamieson

    Products

    Device Name Product Code
    Stimulator, Nerve, Peripheral, Electric KOI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Automated External Defibrillators (Non-Wearable) MKJ
    Compressor, Cardiac, External DRM

    Proprietary Names

    Life Scope Pt BSM-1700 Series Bedside Monitor Lifeline View Auto DDU-2200 Fully-Automatic AED Lifeline Auto DDU-120 Fully-Automatic AED DBP-2003 4-year non-rechargeable battery pack DDP-2002 Pediatric Defibrillation Pads Lifeline DDU-100 Semi-Automatic AED Lifeline ECG+ DDU-2475 Semi-Automatic AED DDP-2001 Adult Defibrillation Pads Lifeline ECG DDU-2450 Semi-Automatic AED Lifeline View DDU-2300 Semi-Automatic AED DDP-200P Pediatric Defibrillation Pads DDP-100 Adult Defibrillation Pads DBP-1400 5-year non-rechargeable battery pack DBP-2013 4-year non-rechargeable TSO battery Lifeline PRO DDU-2400 Semi-Automatic AED DBP-2800 7-year non-rechargeable battery pack Lifeline ARM ACC System RMU-1000 Automated Chest Compressor (ACC) System RMU-2000 Automated Chest Compressor (ACC) System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device