BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PancreasPak Organ Preservation System

    Reg #: 3011175555 · FEI: 3011175555 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PARAGONIX TECHNOLOGIES, INC.
    Registration Number
    3011175555
    FEI Number
    3011175555
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    950 Winter Street, North
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191440

    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

    Proprietary Names

    PancreasPak Organ Preservation System

    Establishment Types

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