BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    CANNULA, O2 CO2 ORAL, ADU, ZOLL LOFLO, 10 (3571ADU-00)

    Reg #: 3010882708 · FEI: 3010882708 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NextPhase Medical Devices Mexico LLC
    Registration Number
    3010882708
    FEI Number
    3010882708
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Tomas Alba Edison 19002, Parque Industrial Tomas Alba Edison, CP
    City
    TIJUANA Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K162832

    Owner / Operator

    Firm Name
    NextPhase Medical Devices LLC Mexico
    Operator Number
    10046837
    Address
    ANDADOR VECINAL NO. 14301, ZONA CERRIL GENERAL
    City
    TIJUANA
    State
    Baja California
    Postal Code
    22330
    Country
    MX
    Correspondent
    James G Bennett

    US Agent

    Business Name
    NextPhase Medical Devices LLC
    Contact Name
    James Bennett
    Address
    88 Airport Drive
    City
    Rochester
    State
    NH
    ZIP
    03867
    Country
    US
    Email
    [email protected]
    Phone
    901 6878811

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Oximeter DQA

    Proprietary Names

    CANNULA, O2 CO2 ORAL, ADU, ZOLL LOFLO, 10 (3571ADU-00) CANNULA, CO2 ORAL, ADU, ZOLL LOFLO, 10 (3570ADU-00) CANNULA, O2 CO2, ADU, ZOLL LOFLO, 10 (3569ADU-00) CANNULA, CO2 ORAL, PED, ZOLL LOFLO, 10 (3570PED-00) CANNULA, CO2, ADU, ZOLL LOFLO, 10 (3568ADU-00) AIRWAY, DEHUM TBG, PED INF, ZOLL LOFLO, 10 (3573INF-00) CANNULA, O2 CO2, INF, 10, ZOLL LOFLO (3569INF-00) AIRWAY, DEHUM TBG, ADU PED, ZOLL LOFLO, 10 (3573ADU-00) AIRWAY, PEDIATRIC INFANT, ZOLL LOFLO, 10 (3572INF-00) CANNULA, CO2, INF, ZOLL LOFLO, 10 (3568INF-00) CANNULA, CO2, PED, ZOLL LOFLO, 10 (3568PED-00) CANNULA, O2 CO2, PED, ZOLL LOFLO, 10 (3569PED-00) CANNULA, O2 CO2 ORAL, PED, ZOLL LOFLO, 10 (3571PED-00) AIRWAY, ADULT PEDIATRIC, ZOLL LOFLO, 10 (3572ADU-00)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)