BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HemoSphere Pressure Cable

    Reg #: 3032916632 · FEI: 3032916632 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    BECTON, DICKINSON AND COMPANY
    Registration Number
    3032916632
    FEI Number
    3032916632
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17200 Laguna Canyon Rd
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223865

    Owner / Operator

    Firm Name
    Becton, Dickinson and Company
    Operator Number
    10093301
    Address
    17200 Laguna Canyon Road
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Karen M O'Leary

    Products

    Device Name Product Code
    Plethysmograph, Impedance DSB
    Adjunctive Open Loop Fluid Therapy Recommender QMS
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Oximeter, Tissue Saturation MUD
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Catheter, Oximeter, Fiber-Optic DQE
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    HemoSphere Pressure Cable Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter, 5-pack Acumen IQ sensor with 84” (213cm) pressure tubing with Acumen IQ fluid meter Acumen IQ sensor with 84” (213cm) pressure tubing, Acumen IQ fluid meter, 5-pack HemoSphere Advanced Monitor Acumen IQ Fluid Meter HemoSphere Oximetry Cable Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter ViewFinder Remote HemoSphere Swan-Ganz Module Heart Reference Sensor HemoSphere ClearSight Module HemoSphere ForeSight Oximeter Cable HemoSphere Vita Monitor Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult with TruWave DPT, 5-pack Pressure Controller Kit Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult, 5-pack HemoSphere VitaWave Module HemoSphere Technology Module HemoSphere Vita Technology Module Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult Acumen AFM Cable

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility