国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
gaia meditech pte.ltd
Class B medical device
GA Health Company Limited
Gastroenterology & Urology
The single use ANDORATE® air/water valve is used to control the air / water function of an endoscope during GI endoscopic procedures. The single use ANDORATE® suction valve is used to control the suction function of an endoscope during endoscopic procedures. The single use ANDORATE® biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus® endoscopes. The ANDORATE® biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port thought the endoscopic procedure and provides access for irrigation. The single use ANDORATE® Auxiliary Water Connector is used in conjunction with irrigation tubing, intended to provide irrigation via irrigation fluids such as sterile water supplied to the Olympus® GI endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
Device System Info:[Sterile Medical Device], ETO sterilization by Goals Sterilization Co., Ltd; Models: Andorate Disposable Valves Set - GAR046, Andorate Disposable Valves Set - GAR004, Andorate Biopsy Irrigator - GAR015, Andorate Disposable Biopsy Valve - GAR028-S, Andorate Air/Water, Suction Biopsy Valve and Auxiliary Water Connector - GAR004C, Andorate Cleaning Adapter and Valve Kit - GAR3804, Andorate A/W Channel Cleaning Adapter + 4-piece Valve Kit - GAR3846, Andorate 2-piece Cleaning Adapter + 3-piece Valve Kit - GAR387504, Andorate 2-piece Cleaning Adapter + 4-piece Valve Kit - GAR387546, Andorate 3-piece Valve Kit - GAR065, Andorate 4-piece Valve Kit - GAR066, Andorate A/W Channel Cleaning Adapter + 3-piece Valve Kit - GAR3865, Andorate A/W Channel Cleaning Adapter + 4-piece Valve Kit - GAR3866, Andorate 2-piece Cleaning Adapter + 3-piece Valve Kit - GAR387565, Andorate 2-piece Cleaning Adapter + 4-piece Valve Kit - GAR387566, Andorate 2-piece Valve Kit (Suction and Biopsy Valve) - GAR109
2019-06-17