BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NIHON KOHDEN ORANGEMED, LLC

    Reg #: 3014631252 · FEI: 3014631252 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    NIHON KOHDEN ORANGEMED, LLC
    Registration Number
    3014631252
    FEI Number
    3014631252
    Status
    Active
    Expiry Year
    2026
    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
    Sv70 Ventilator MNT
    Ventilator, Continuous, Facility Use CBK
    Tubing, Pressure And Accessories BYX

    Proprietary Names

    Nihon Kohden NPPV Cap-ONE Mask Set Nihon Kohden Exhalation Port Nihon Kohden NKV-330 Ventilator System Nihon Kohden NKV-550 Series Ventilator System O2 Manifold Nihon Kohden NKV-440 Ventilator System

    Establishment Types

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