Recently, the innovative product integrated membrane oxygenator of Dongguan Kewei Medical Device Inc. is approved for marketing by China NMPA.

　　The integrated membrane oxygenator is composed of oxygenator components (integrated gas exchanger and heat exchanger) and a venous blood reservoir system, which can be used in combination. The oxygenator components integrate the arterial micro thrombus filtering function (optional). This product is suitable for patients weighing more than 10kg. The oxygenator is applicable to oxygenation of blood, elimination of carbon dioxide and regulation of blood temperature during cardiopulmonary bypass surgery (up to 6 hours). The venous blood reservoir system is used to collect, store and filter blood.

　　The product adopts a spiral flow guide integrated structure, which guides the rapid dispersion of blood flow at the blood inlet. When entering the tempering chamber for gas exchange, the secondary diversion of blood is realized through the porous flow guide structure from inside to outside, so that the blood is evenly distributed in the whole oxygenator chamber, shortening the blood flow path, improving the gas exchange capacity of the oxygenator and reducing the pressure loss. The integrated structure design in clinical application has the clinical significance of reducing the overall pre-charging volume and hemodilution.

　　The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.