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Intra-Aortic Balloon(IAB) Catheter Kit主动脉内球囊反搏导管及附件

Brand Arrow箭牌
Manufacturer Arrow International, Inc.箭牌国际公司
Production Address 16 Elizabeth Drive Chelmsford Massachusetts,01824,USA
Intended Use This product is used for intra-aortic balloon counterpulsation therapy. During treatment, the balloon inflates and expands during cardiac diastole, and deflates and contracts during cardiac systole, thus increasing blood supply to the myocardium and reducing the workload of the left ventricle.该产品用于主动脉内球囊反搏疗法。治疗时球囊在心脏舒张期充气扩张、在心脏收缩期放气收缩,以此来增加对心肌的血液供应,并降低左心室的工作负荷。
References IAB-05830-U, IAB-05840-U, IAB-06830-U, IAB-06840-U, IAB-S730C, IAB-S840C, IAB-R950-U ………
Manufacturer’s Website https://www.teleflex.com/usa/en/product-areas/interventional/cardiac-assist/intra-aortic-balloon-catheters/
Product Brochure
Registration Certificate 国械注进20153032353

Brand

The product consists of three parts: a catheter tray, a puncture tray, and a connecting tube with connectors. The catheter tray includes components such as the intra-aortic balloon counterpulsation catheter, the counterpulsation pump connecting tube, syringe, extension tube with three-way stopcock, and extension tube. The puncture tray includes components such as sheath with dilator, sheath with dilator and side arm, dilator, puncture needle, guidewire, and surgical knife. The catheter body is made of polyimide. The counterpulsation catheter has a hydrophilic coating, is sterilized with ethylene oxide, and is for single-use. The shelf life is two years.

该产品分三个部分:导管托盘、穿刺托盘、带接头的连接管。导管托盘含组件:主动脉内球囊反搏导管,反搏泵连接管,注射器,带三通的延长管,延长管等。穿刺托盘含组件:带扩张器的鞘,带扩张器、侧臂的鞘,扩张器,穿刺针,导丝,手术刀。管身材料为聚酰亚胺。反搏导管含有水滑涂层,环氧乙烷灭菌,一次性使用。货架有效期两年。

Risk-Based Classification风险管理类别

Product Status产品状态

Inactive

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