BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NextPhase Medical Devices, LLC

    Reg #: 3003174284 · FEI: 3003174284 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    NextPhase Medical Devices, LLC
    Registration Number
    3003174284
    FEI Number
    3003174284
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    110 FORBES BLVD.
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162332

    Owner / Operator

    Firm Name
    NextPhase Medical Devices, LLC
    Operator Number
    9050650
    Address
    110 FORBES BLVD., --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    Products

    Device Name Product Code
    Pump, Infusion, Implanted, Programmable LKK
    Continuous Measurement Thermometer FLL
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Breathing Frequency BZQ
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph DPS
    Stethoscope, Electronic DQD
    Plethysmograph, Impedance DSB
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Artificial Heart LOZ
    Hysteroscope Accessories NWW
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Arthroscope HRX

    Proprietary Names

    Prometra Codman OR Prep Kits CO2 Insufflator HTA Hysteroscope Adapter Sensinel Cardiopulmonary Management System

    Establishment Types

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