Edwards Lifesciences, LLC

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)

Cardiovascular Devices

2

No

US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX

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).

Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740, 58326741, 58329130, and 58329131

Cardiovascular Devices

2

No

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.

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.

595531157

Cardiovascular Devices

2

No

Nationwide Distribution including MO and MI.

"***Flo Trac Sensor Model MHD85***" || Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.

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.

Cardiovascular Devices

2

No

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.

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.

59267057

Cardiovascular Devices

2

No

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).

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. || For use in patients who require hemodynamic monitoring.