BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BREAS MEDICAL, INC.

    Reg #: 3010817335 · FEI: 3010817335 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    BREAS MEDICAL, INC.
    Registration Number
    3010817335
    FEI Number
    3010817335
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    16 Esquire Road
    City
    N Billerica
    State
    MA
    ZIP
    01862
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232365

    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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Ventilator, Continuous, Facility Use CBK
    Oximeter DQA
    Continuous, Ventilator, Home Use NOU
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Accessory To Continuous Ventilator (Respirator) MOD
    Sv70 Ventilator MNT
    Ventilator, Continuous, Non-Life-Supporting MNS
    Ventilator, Non-Continuous (Respirator) BZD
    Stand, Infusion FOX
    Device, Positive Pressure Breathing, Intermittent NHJ
    Mouthpiece, Breathing BYP

    Proprietary Names

    Vivo 45 LS Vivo Accessories EveryWare Z2 Vivo Trolley and Accessories Vivo 45LS Vivo 65 Z1 Clearo Clearo Patient Circuit Americas Vivo 1, Vivo 2 Vivo 55/Vivo 65 Accessories Vivo 55 Vivo 3

    Establishment Types

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