BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Acumen Assisted Fluid Management

    Reg #: 2015691 · FEI: 2015691 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES LLC
    Registration Number
    2015691
    FEI Number
    2015691
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ONE EDWARDS WAY
    City
    IRVINE
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213682

    Owner / Operator

    Firm Name
    Edwards Lifesciences LLC
    Operator Number
    9040666
    Address
    One Edwards Way
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Denny Kouri

    Products

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

    Proprietary Names

    Acumen Assisted Fluid Management HemoSphere ClearSight Module HemoSphere Technology Module HemoSphere ForeSight Oximeter Cable HemoSphere Pressure Cable HemoSphere Oximetry Cable Acumen Hypotension Prediction Index Viewfinder Remote HemoSphere Advanced Monitor HemoSphere Swan-Ganz Module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility