BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vivo 55

    Reg #: 3010817335 · FEI: 3010817335 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    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
    K123144

    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
    Continuous, Ventilator, Home Use NOU
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter DQA
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Vivo 55 Vivo 55/Vivo 65 Accessories

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198