BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nihon Kohden NKV-330 Ventilator System

    Reg #: 3014631252 · FEI: 3014631252 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NIHON KOHDEN ORANGEMED, LLC
    Registration Number
    3014631252
    FEI Number
    3014631252
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1800 E. Wilshire Avenue
    City
    Santa Ana
    State
    CA
    ZIP
    92705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213521

    Owner / Operator

    Firm Name
    Nihon Kohden OrangeMed, LLC
    Operator Number
    10059216
    Address
    1800 E. Wilshire Avenue
    City
    Santa Ana
    State
    CA
    Postal Code
    92705
    Country
    US
    Correspondent
    Sheryl Higgins

    Products

    Device Name Product Code
    Ventilator, Continuous, Minimal Ventilatory Support, Facility Use MNT

    Proprietary Names

    Nihon Kohden NKV-330 Ventilator System Nihon Kohden Exhalation Port Nihon Kohden NPPV Cap-ONE Mask Set

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device