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    FDA Registration Active 🇺🇸 United States

    NT902045 - NATUS DP PEDIATRIC VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O

    Reg #: 2023988 · FEI: 2023988 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    43
    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
    K152897

    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

    NT902045 - NATUS DP PEDIATRIC VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O NT902123 - NATUS DP PEDIATRIC VALVE UNIT, WHITE (LOW): 40-80 mmH2O NT901145 - NATUS DP STANDARD VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O NT901113 - NATUS DP STANDARD VALVE UNIT, BLUE (VERY LOW): 15-40 mmH2O NT901143 - NATUS DP STANDARD VALVE UNIT, YELLOW (MEDIUM): 80-120 mmH2O NT908162 - Natus DP Pediatric Burr Hole Shunt System, Brown (High): 120-170 mmH2O NT955112 - BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - 6.4 mm - Depth 2.5 mm) NT955143 - BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - 10 mm - Depth 0.8 mm) NT901165 - NATUS DP STANDARD VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O NT907122 - Natus DP Standard Burr Hole Shunt System, White (Low): 40-80 mmH2O NT901123 - NATUS DP STANDARD VALVE UNIT, WHITE (LOW): 40-80 mmH2O NT955111 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - 6.4 mm - Depth 0.8 mm) NT903435 - Gravity Compensating Accessory, Medium Pressure Range (Yellow) NT901142 - NATUS DP STANDARD VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O NT901112 - NATUS DP STANDARD VALVE SYSTEM, BLUE (VERY LOW): 15-40 mmH2O NT901182 - NATUS DP STANDARD VALVE SYSTEM, GREEN (VERY HIGH): 170-230 mmH2O NT902080 - NATUS DP PEDIATRIC VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O NT901410 - STAINLESS STEEL STRAIGHT CONNECTORS NT901162 - NATUS DP STANDARD VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O NT908112 - Natus DP Pediatric Burr Hole Shunt System, Blue (Very Low): 15-40 mmH2O NT908122 - Natus DP Pediatric Burr Hole Shunt System, White (Low): 40-80 mmH2O NT907162 - Natus DP Standard Burr Hole Shunt System, Brown (High): 120-170 mmH2O NT955142 - BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - 10 mm - Depth 2.5 mm) NT901414 - STAINLESS STEEL "T" CONNECTORS NT901122 - NATUS DP STANDARD VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O NT902545 - NATUS DP PEDIATRIC VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O NT908142 - Natus DP Pediatric Burr Hole Shunt System, Yellow (Medium): 80-120 mmH2O NT902125 - NATUS DP PEDIATRIC VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O NT902525 - NATUS DP PEDIATRIC VALVE SYSTEM, BROWN (HIGH): 120-170 mmH2O NT955141 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - 10 mm - Depth 0.8 mm) NT901412 - STAINLESS STEEL "Y" CONNECTORS NT903440 - Gravity Compensating Accessory, High Pressure Range (Brown) NT955113 - BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - 6.4 mm - Depth 0.8 mm) NT901163 - NATUS DP STANDARD VALVE UNIT, BROWN (HIGH): 120-170 mmH2O NT901411 - STAINLESS STEEL RIGHT ANGLE CONNECTORS NT901125 - NATUS DP STANDARD VALVE SYSTEM, WHITE (LOW): 40-80 mmH2O NT955110 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - 6.4 mm - Depth 2.5 mm) NT901183 - NATUS DP STANDARD VALVE UNIT, GREEN (VERY HIGH): 170-230 mmH2O NT955140 - BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - 10 mm - Depth 2.5 mm) NT903430 - Gravity Compensating Accessory, Low Pressure Range (White) NT902580 - NATUS DP PEDIATRIC VALVE SYSTEM, YELLOW (MEDIUM): 80-120 mmH2O NT907142 - Natus DP Standard Burr Hole Shunt System, Yellow (Medium): 80-120 mmH2O NT902012 - NATUS DP PEDIATRIC VALVE SYSTEM, BLUE (VERY LOW): 15-40 mmH2O

    Establishment Types

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