BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL (3471ADU-00)

    Reg #: 3010882708 · FEI: 3010882708 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    1

    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
    K053174

    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, Carbon-Dioxide, Gaseous-Phase CCK

    Proprietary Names

    LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL (3471ADU-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL (3470ADH-00) LoFlo CO2 Sampling Cannula (1149478) LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL (3469INF-00) LoFlo Sampling Line Kit w/Dehumidification Tubing (1149495) LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL (3468INH-00) LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL (3473INF-00) LoFlo Sampling Line Kit (1149494) LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL (3470PED-00) LoFlo Airway Adapter Kit INFANT/NEONATAL (3472INF-00) LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL (3469PED-00) LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric (3473ADU-00) LoFlo CO2 Sampling Cannula ADULT NASAL (3468ADU-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL (3469ADH-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL (3469PEH-00) LoFlo SAMPLING LINE KIT w/Dehumidification Tubing (3475-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL (3469INH-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL (3468PEH-00) LoFlo CO2 Sampling Cannula (1149435) LoFlo CO2 Sampling Cannula (1149476) LoFlo Airway Adapter Kit ADULT/PEDIATRIC (3472ADU-00) LoFlo CO2 Sampling Cannula (1149474) Sample Line-Female Luer Connector (3476-00) LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL (3468INF-00) LoFlo SAMPLING LINE KIT (3474-00) LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL (3471PED-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL (3471ADH-00) LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL (3470ADU-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL (3470PEH-00) LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL (3468ADH-00) LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL (3469ADU-00) LoFlo CO2 Sampling Cannula (1149484) LoFlo CO2 Sampling Cannula PEDIATRIC NASAL (3468PED-00) LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL (3471PEH-00)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)