BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG

    Reg #: 9615817 · FEI: 3003081151 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    94
    Establishment Types
    1
    Classifications
    23

    Registration Details

    Registration Name
    CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG
    Registration Number
    9615817
    FEI Number
    3003081151
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PARQUE INDUSTRIAL ITABO, KM. 18.5 CARR. SANCHEZ
    City
    HAINA San Cristobal
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K190130

    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

    US Agent

    Business Name
    Becton, Dickinson & Company
    Contact Name
    Karen O'Leary
    Address
    17200 Laguna Canyon Rd, Irvine
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 6109179

    Products

    Device Name Product Code
    Catheter, Flow Directed DYG
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Catheter, Embolectomy DXE
    Catheter, Continuous Flush KRA
    Plethysmograph, Impedance DSB
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Probe, Thermodilution KRB
    Clamp, Surgical, General & Plastic Surgery GDJ
    Transducer, Blood-Pressure, Extravascular DRS
    Computer, Diagnostic, Programmable DQK
    Transducer, Pressure, Catheter Tip DXO
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Oximeter, Fiber-Optic DQE
    Clamp, Vascular DXC
    Oximeter, Tissue Saturation MUD
    Adjunctive Open Loop Fluid Therapy Recommender QMS
    Continuous Measurement Thermometer FLL
    Stopcock, I.V. Set FMG
    Set, Administration, Intravascular FPA
    Stand, Infusion FOX
    Medium-Term Adjunctive Predictive Cardiovascular Indicator QNL
    Cerebral Oximeter QEM

    Proprietary Names

    Swan Ganz Catheters ClearSight finger cuff Accumen IQ finger cuff Fogarty VAMP VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION CO-SET Pressure Controller EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Pressure Controller Kit Cuffs or ClearSight System EV1000 Clinical Platform FloTrac Sensor FloTrac Jr Sensor Transducer, blood-pressure, extravascular VolumeView sensor Acumen IQ sensor HemoSphere Pressure Cable HemoSphere ClearSight Module VitaWave Plus finger cuff HemoSphere Vita Monitor HemoSphere Technology Module HemoSphere Vita Technology Module Acumen IQ Plus Finger Cuff HemoSphere Advanced Monitor Smart Pressure Controller HemoSphere VitaWave module DISPOSABLE PRESSURE DOME Dome TruWave Disposable Pressure Transducer Transducers Pressure Monitoring Kit with TruWave Disposable Pressure FloTrac Jr sensor ClearSight Jr finger cuff Swan-Ganz Jr catheter HemoSphere VASCULAR CLAMP Fogarty 6mm Spring Clip Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter, 5-pack ViewFinder Remote Acumen IQ sensor with 84” (213cm) pressure tubing, Acumen IQ fluid meter, 5-pack Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult, 5-pack HemoSphere Oximetry Cable HemoSphere Swan-Ganz Module Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult with TruWave DPT, 5-pack HemoSphere ForeSight Oximeter Cable Acumen AFM Cable Heart Reference Sensor HemoSphere VitaWave Module Acumen IQ sensor with 84” (213cm) pressure tubing with Acumen IQ fluid meter Acumen IQ Fluid Meter Acumen IQ finger cuff Acumen IQ finger cuff adult VitaWave finger cuff adult FORE-SIGHT ELITE PRE-AMP CABLE 4m and 6.5m FORE-SIGHT ELITE TISSUE OXIMETER SENSORS, ForeSight Sensors FORE-SIGHT ELITE Tissue Oximeter VAMP Venous/Arterial Blood Management Protection System TruWave™ Disposable Pressure Transducers Disposable Pressure Transducer Flotrac Sensor-MHD6AZ Flotrac Sensor-MHD6AZ5 Flotrac Sensor-MHD6AZA VolumeView Sensor-VLV8R5 Flotrac Sensor-MHD8S102 Flotrac Sensor-MHD6AZ VolumeView Sensor-VLV6R5 Flotrac Sensor-MHD6C502 Acumen IQ Sensor Flotrac Sensor-MHD8 Flotrac Sensor-MHD65 Flotrac Sensor-MHD6 Flotrac Sensor-MHD8 Flotrac Sensor-MHD85 Flotrac Sensor-MHD8C503 VAMP Optima closed blood sampling system Fogarty Softjaw Spring Clip VAMP Plus Venous/Arterial Blood Management Protection System TruClip PX 1800 TRUCLIP CATHETER TIP, PRESSURE TRANSDUCER TruWave HemoSphere Alta Advanced Monitor HemoSphere Alta - Monitor Pressure Cable Acumen AFM cable - HemoSphere Alta monitor ForeSight IQ Sensor ClearSight and AcumenIQ finger cuffs Disposable Pressure Transducer TruWave™ Disposable Pressure Transducers Parallel Jaw Spring Clamp EverGrip Insert Handleless Clamp Fogarty-Hydragrip Surg Clamp Insert PediaSat Oximetry Catheter

    Establishment Types

    Manufacture Medical Device