BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vivo 1, Vivo 2

    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
    K240778

    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, Non-Life-Supporting MNS
    Continuous, Ventilator, Home Use NOU

    Proprietary Names

    Vivo 1, Vivo 2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198