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510(k) Data Aggregation
(146 days)
TIANYI Extracorporeal Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer.
TIANYI Extracorporeal Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
TIANYI Extracorporeal Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T hemodialysis Machines.
The proposed device, TIANYI Extracorporeal Blood Tubing Set, is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The device is intended for acute and chronic hemodialysis therapy. The TIANYI Extracorporeal Blood Tubing Set is intended to be used with Fresenius Medical Care 2008 Series K, K2and T Hemodialysis Machines. The proposed device is provided sterile and for single use. It is for Rx use.
TIANYI Extracorporeal Blood Tubing Set is composed of two parts, the Arterial Line (AL) and the Venous Line (VL). Arterial Line is coded red, and Venous Line is coded blue.
The device consists of Dialyzer connector, Dialyser connector cap, Main tubing, Pump segment, Pump connectors, Arterial Chamber, Venous Chamber, Filter of venous chamber, Chamber caps, Sampling port, Clamps, Patient end (Male rotating hub luer and Rotatable threaded collar), Female luer lock, Recirculation connector, Infusion line, Pressure monitoring line, Transducer protector, Heparin line, Heparin female luer lock, Female luer cap, T connector, and priming set.
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