BEUDAMED
    FDA Registration Active 🇨🇳 China

    Single Limb Circuit for Pneupac Ventilators

    Reg #: 3006783791 · FEI: 3006783791 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GaleMed (Xiamen) Co., Ltd.
    Registration Number
    3006783791
    FEI Number
    3006783791
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road, 361026 Fujian Province, China
    City
    XIAMEN Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K123957

    Owner / Operator

    Firm Name
    GaleMed Corporation
    Operator Number
    8043316
    Address
    87, LI-GONG 2ND RD.,
    City
    Wu-jia
    State
    Yilan
    Postal Code
    268
    Country
    TW

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr. NE, St. Petersburg, FL 33704, USA
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076060

    Products

    Device Name Product Code
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Attachment, Breathing, Positive End Expiratory Pressure BYE

    Proprietary Names

    Single Limb Circuit for Pneupac Ventilators Dual Limb Circuit for Pneupac Ventilators Single Limb Circuit for Pneupac® DEMAND type Ventilators Single Limb Circuit for Pneupac® paraPAC plusTM Ventilators with Internal Pressure Monitoring Line with In-Line Filter Dual Limb Circuit for Pneupac® babyPACTM Ventilators Single Limb Circuit for Pneupac® DEMAND type Ventilators, with PEEP Valve Single Limb Circuit for Pneupac® DEMAND type Ventilators, with PEEP Valve and Pressure Monitoring Line with In-Line Filt Single Limb Circuit for Pneupac® paraPAC plusTM Ventilator with 0-20 cmH2O PEEP Valve and Internal Pressure Monitoring

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)