BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Heliox Low Flow Sentry Blender

    Reg #: 3015973929 · FEI: 3015973929 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Vyaire Medical, Inc.
    Registration Number
    3015973929
    FEI Number
    3015973929
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    510 Technology Dr.
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092484

    Owner / Operator

    Firm Name
    Vyaire Medical
    Operator Number
    10053153
    Address
    26125 North Riverwoods Blvd
    City
    Mettawa
    State
    IL
    Postal Code
    60045
    Country
    US

    Products

    Device Name Product Code
    Mixer, Breathing Gases, Anesthesia Inhalation BZR

    Proprietary Names

    Heliox Low Flow Sentry Blender

    Establishment Types

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