Edwards Lifesciences, LLC

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Description

19 dispositivos en la base de datos

  • Modelo / Serial
    HEM1 UDI 00690103197006 (Serial No. 13800180, 13800185, 13800193, 13800195, 13800228, 13800162, 13800168, 13800171, 13800208, 13800210, 13800211, 13800126, 13800128, 13800129, 13800130, 13800132, 13800133, 13800135, 13800139, 13800140, 13800144, 13800146, 13800147, 13800148, 13800150, 13800187, 13800189, 13800131, 13800134, 13800136, 13800191, 13800192, 13800197, 13800172, 13800173, 13800159, 13800184, 13800188, 13800339, 13800355, 13800199, 13800200, 13800141, 13800249, 13800258, 13800259, 13800260, 13800263, 13800265, 13800268, 13800270, 13800176, 13800177, 13800179, 13800186, 13800225, 13800227, 13800230, 13800196, 13800124, 13800125, 13800137, 13800138, 13800142, 13800143, 13800145, 13800149, 13800151, 13800152); HEMSGM10 UDI 00690103196993 (Serial No. 13600223, 13600224, 13600225, 13600226, 13600257, 13600196,  13600197, 13600198, 13600227, 13600228, 13600229, 13600158, 13600159, 13600160, 13600161, 13600162, 13600163, 13600164, 13600165, 13600166, 13600167, 13600168, 13600169, 13600170, 13600171, 13600206, 13600207, 13600145, 13600146, 13600147, 13600208, 13600209, 13600211, 13600199, 13600201, 13600193, 13600194, 13600195, 13600390, 13600421, 13600212, 13600213, 13600202, 13600203, 13600204, 13600205, 13600255, 13600256, 13600258, 13600210, 13600148, 13600149, 13600150, 13600151 13600152, 13600153, 13600154, 13600155, 13600156, 13600157); HEMOXSC100 UDI 00690103196986 (Serial No. 13700241, 13700246, 13700247, 13700248, 13700303, 13700188, 13700189, 13700190, 13700280, 13700282, 13700291, 13700149, 13700150, 13700151, 13700152, 13700153, 13700154, 13700155, 13700156, 13700157, 13700158, 13700159, 13700160, 13700161, 13700162, 13700174, 13700177, 13700136, 13700137, 13700138, 13700179, 13700199, 13700182, 13700191, 13700192, 13700193, 13700194, 13700180, 13700185, 13700186, 13700183, 13700187, 13700201, 13700205, 13700215, 13700236, 13700240, 13700258, 13700265, 13700270, 13700271, 13700195, 13700196, 13700197, 13700198, 13700252, 13700301, 13700363, 13700175, 13700139, 13700140, 13700141, 13700142, 13700143, 13700144, 13700145, 13700146, 13700147, 13700148)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX
  • Descripción del producto
    Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). || Product Usage: || The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).
  • Modelo / Serial
    Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740, 58326741, 58329130, and 58329131
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International Distribution --- including countries of Austria, Belgium, Bulgaria, Switzerland, Czech republic, Germany, Denmark, United Kingdom, Italy, Luxembourg, Netherlands, Sweden, Slovak Republic, South Africa, and Taiwan.
  • Descripción del producto
    Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter || Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
  • Modelo / Serial
    595531157
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including MO and MI.
  • Descripción del producto
    "***Flo Trac Sensor Model MHD85***" || Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
  • Modelo / Serial
    59184554, 59187809, 59191725, 59221801, 59227844, 59238613, 59326333, 59356987, 59401041,  59222349, 59227178, 59234808, 59284693, 59328047, 59270408, 59284617, 59276238, 59401734, 59270380, 59319038, 59306624, 59390840, 59195810, 59331224, 59397181, 59291446, 59272771.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, HI, ID, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WI) and Europe.
  • Descripción del producto
    Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. || Blood sampling system used on patients requiring periodic withdrawal of blood samples.
  • Modelo / Serial
    59267057
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).
  • Descripción del producto
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. || For use in patients who require hemodynamic monitoring.
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Más información acerca de la data acá

  • Dirección del fabricante
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Edwards Lifesciences, LLC, 12050 S Lone Peak Pkwy, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA