BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    AIRWAY, ADU-PED, SLM LOFLO (3672ADU-00)

    Reg #: 3010882708 · FEI: 3010882708 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    3

    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
    K031124

    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
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    AIRWAY, ADU-PED, SLM LOFLO (3672ADU-00) CANNULA NASAL/ORAL CO2/O2 ADU 704-0020-00 (3671PED-00) AIRWAY ADAPTER PED/INF NAFION 704-0026-00 (3673INF-00) CANNULA NASAL CO2 ADULT 704-0010-00 (3668ADU-00) SAMPLE LINE MALE LUER NAFION 704-0028-00 (3675-00) SAMPLE LINE MALE LUER 704-0027-00 (3674-00) CANNULA NASAL CO2 PED 704-0012-00 (3668PED-00) CANNULA NASAL CO2/O2 PED 704-0016-00 (3669PED-00) AIRWAY ADAPTER KIT, PED/INF, 704-0024-00 (3672INF-00) CANNULA NASAL CO2/O2 INF 704-0015-00 (3669INF-00) AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10 (3673ADU-00) CANNULA NASAL/ORAL CO2 ADU 704-0017-00 (3670ADU-00) CANNULA, NASAL, CO2/O2 ADU, 704-0014-00 (3669ADU-00) CANNULA, NASAL/ORAL, CO2/O2 ADU, 704-0020-00 (3671ADU-00)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)