BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vivo 3

    Reg #: 3010817335 · FEI: 3010817335 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BREAS MEDICAL, INC.
    Registration Number
    3010817335
    FEI Number
    3010817335
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    16 Esquire Road
    City
    N Billerica
    State
    MA
    ZIP
    01862
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240779

    Owner / Operator

    Firm Name
    BREAS MEDICAL, INC.
    Operator Number
    10046641
    Address
    16 Esquire Road
    City
    N Billerica
    State
    MA
    Postal Code
    01862
    Country
    US

    Products

    Device Name Product Code
    Ventilator, Continuous, Minimal Ventilatory Support, Facility Use MNT
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    Vivo 3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198