BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PARAGONIX TECHNOLOGIES, INC.

    Reg #: 3011175555 · FEI: 3011175555 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    PARAGONIX TECHNOLOGIES, INC.
    Registration Number
    3011175555
    FEI Number
    3011175555
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    950 Winter Street, North
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192869

    Owner / Operator

    Firm Name
    Paragonix Technologies
    Operator Number
    10057453
    Address
    950 Winter Street, North
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    System, Perfusion, Kidney KDN
    System And Accessories, Isolated Heart, Transport And Preservation MSB

    Proprietary Names

    SherpaPak™ LIVERguard SherpaPak™ LUNGguard PancreasPak Organ Preservation System BAROguard KidneyVault SherpaPak Kidney Transport System SherpaPak Cardiac Transport System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198