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    FDA Registration Active 🇺🇸 United States

    NT11811 - Contour-Flex Valve System, Regular, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O

    Reg #: 2023988 · FEI: 2023988 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Natus Medical Incorporated
    Registration Number
    2023988
    FEI Number
    2023988
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6225 Nancy Ridge Dr
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033698

    Owner / Operator

    Firm Name
    Natus Medical Incorporated
    Operator Number
    9004873
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US
    Correspondent
    Sanjay Mehta

    Products

    Device Name Product Code
    Shunt, Central Nervous System And Components JXG

    Proprietary Names

    NT11811 - Contour-Flex Valve System, Regular, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O NTCFSM - Contour-Flex Valve Unit, Small, Medium Pressure At 20 ml/hr: 6.7 - 11.8 cm H2O NTCFRM - Contour-Flex Valve Unit, Regular, Medium Pressure At 20 ml/hr: 6.7 - 11.8 cm H2O NTPC1 - Peritoneal Catheter F7, 91 cm, With Radiopaque Stripe and Length Markers NT11813 - Contour-Flex Valve System, Regular, High Pressure At 20 ml/hr: 12.7-18 cm H2O NT9MD102B - STRAIGHT VENTRICULAR CATHETER F8, 15 cm, WITH RADIOPAQUE STRIP & LENGTH MARKERS NT14087 - Contour-Flex Valve System, Small, High Pressure At 20 ml/hr: 12.7-18 cm H2O NT14085 - Contour-Flex Valve System, Small, Low Pressure At 20 ml/hr: 1.2-5.8 cm H2O NT14086 - Contour-Flex Valve System, Small, Medium Pressure At 20 ml/hr: 6.7-11.8 cm H2O NT11812 - Contour-Flex Valve System, Regular, Medium Pressure At 20 ml/hr: 6.7-11.8 cm H2O NTCFRH - Contour-Flex Valve Unit, Regular, High Pressure At 20 ml/hr: 12.7 - 18 cm H2O NTCFSH - Contour-Flex Valve Unit, Small, High Pressure At 20 ml/hr: 12.7 - 18 cm H2O NTCFRL - Contour-Flex Valve Unit, Regular, Low Pressure At 20 ml/hr: 1.2 - 5.8 cm H2O NTVC1 - Straight Ventricular Catheter F8, 25 cm, With Length Markers NTCFSL - Contour-Flex Valve Unit, Small, Low Pressure At 20 ml/hr: 1.2 - 5.8 cm H2O

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility