BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PVC Resuscitator and Accessories

    Reg #: 3015191173 · FEI: 3015191173 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    EXIN MEDICAL TECHNOLOGY COMPANY, LLC
    Registration Number
    3015191173
    FEI Number
    3015191173
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2106 Scarlet Thistle Court
    City
    Katy
    State
    TX
    ZIP
    77494
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170663

    Owner / Operator

    Firm Name
    Exin Medical Technology Company, LLC
    Operator Number
    10059125
    Address
    2106 scarlet thistle cr
    City
    Katy
    State
    TX
    Postal Code
    77494
    Country
    US
    Correspondent
    Frank Chiang

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP

    Proprietary Names

    PVC Resuscitator and Accessories

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198