BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    ARYA Zen-O Lite Portable Oxygen Concentrator Model RS-00600

    Reg #: 3011895992 · FEI: 3011895992 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GAS CONTROL EQUIPMENT LTD
    Registration Number
    3011895992
    FEI Number
    3011895992
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Empress Park, Penny Lane
    City
    Haydock St. Helens
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K162433

    Owner / Operator

    Firm Name
    Gas Control Equipment LTD
    Operator Number
    10056354
    Address
    100 Empress Park, Penny Lane
    City
    Haydock
    State
    St. Helens
    Postal Code
    WA119DB
    Country
    GB

    US Agent

    Business Name
    Ohio Medical LLC
    Contact Name
    JESSICA BARRILE
    Address
    1111 Lakeside Dr
    City
    Gurnee
    State
    IL
    ZIP
    60031
    Country
    US
    Email
    [email protected]
    Phone
    847 8556318

    Products

    Device Name Product Code
    Generator, Oxygen, Portable CAW

    Proprietary Names

    ARYA Zen-O Lite Portable Oxygen Concentrator Model RS-00600 GCE Zen-O Lite Clarity Portable Oxygen Concentrator Model RS-00600C GCE Zen-O Lite Portable Oxygen Concentrator Model RS-00600 GCE Zen-O Clarity Portable Oxygen Concentrator Model RS-00500C GCE Zen-O Portable Oxygen Concentrator Model RS-00500

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility