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The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during GI endoscopic procedures. 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® Biopsy Valve is used to cover the opening to the biopsy/suction channel of gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through 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 fluids such as sterile water supplied to the Gl endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of crosscontamination of the irrigation system.

The subject devices are intended for single use. The components included are the ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and ANDORATE® Auxiliary Water Connector. The suction valve controls the suction function, the air/water valve controls air and water flow, the biopsy valve covers the biopsy port and allows access for devices, and the auxiliary water connector provides irrigation fluids and has a one-way valve. The devices are packed in a sealed pouch and are supplied sterile.

Protego Air Water Connector: The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. Protego Air Water Bottle Tubing: Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device. Protego Hybrid Tubing: Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2, water and irrigation during endoscopic procedures in conjunction with an irrigation pump. It is a 24-hour multi-patient use device.

The Protego Air Water Connector is intended for single use then discarded. The Protego Air Water Bottle Tubing and Protego Hybrid Tubing are intended for 24-hour use then discarded. All Protego Air Water Connector, Protego Air Water Bottle Tubing and Protego Hybrid Tubing are provided sterile. The Air Water Connector is used in conjunction with air water bottle tubing or hybrid tubing, intended to supply air/CO2 and water during gastro-intestinal endoscopic procedure. It is connected to the air/water port of the endoscope to provide connection from the air/water bottle tubing to the endoscope. The Air Water Bottle Tubing is connected to the air/water port of the endoscope and the sterile water bottle to supply air/ CO2 or sterile water during the GI endoscopic procedure. The Hybrid Tubing is composed of air/water bottle tubing and irrigation tubing, which is intended to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastro-intestinal endoscopic procedure.

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 GI endoscopic procedures. The single use ANDORATE® Biopsy Valve is used to cover the opening to the biopsy/suction channel of Olympus® gastro-intestinal endoscopes. The Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port through 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. The Auxiliary Water Connector is manufactured with a one-way valve to minimize the risk of cross-contamination of the irrigation system.

The subject devices are intended for single use. The components included in the submission are ANDORATE® Suction Valve, ANDORATE® Air/Water Valve, ANDORATE® Biopsy Valve, and AQUAPULSE® Auxiliary Water Connector. The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscope image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures. The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The auxiliary water connector is manufactured for use in conjunction with irrigation tubing, and Olympus endoscope. It is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle. The subject devices are packed in a sealed pouch and are supplied sterile. The subject devices in this submission have the same operation and method of action with the predicate devices.

The single use ANDORATE® Suction Valve is used to control the suction function of an endoscope during the endoscopic procedure. The single use ANDORATE® Biopsy Valve is used to cover the biopsy/suction channel of endoscope. The biopsy valve provides access for endoscopic device passage and exchange and minimizes leakage of biomaterial from the biopsy port through the endoscopic procedure.

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the bronchoscope and the biopsy valve is designed to be attached to the biopsy port of the bronchoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the bronchoscopic image while biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The suction valve and biopsy valve kit is compatible with Olympus® 160/180/190/260/290 Series Bronchoscopes.

The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrontestinal endoscopic procedures when used in conjunction with an irrigation pump.

The AquaPulse® Irrigation Tubing is intended for 24-hour use and then discarded. The irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The irrigation tubing is individually packed in sealed package, sold as a sterile device. The irrigation tubing is designed to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

The single use andorate® Suction Valve is used to control the suction of an endoscope during GL endoscopic procedures. The single use andorate® Air/Water Valve is used to control the air / water function of an endoscope during GI endoscopic procedures.

The subject devices are intended for single-use and are supplied sterile. The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscope image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.

The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.

The Andorate® Universal Endoscope Tip Guard is intended for single use. The universal endoscope tip guard is used to cover distal end of an endoscope prior to transportation and storage. The universal endoscope tip quard is individually packed in sealed package, and it is available both non-sterile and sterile.

The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.

The AquaPulse® Irrigation Tubing is intended for 24-hour use and then discarded. The irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The irrigation tubing is individually packed in sealed package, sold as a sterile device. The irrigation tubing is designed to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

The Andorate® Disposable Suction Valve is used to control the suction of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure. The Andorate® Disposable Air/Water valve is used to control the air/water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure.

The subject devices are intended for single-use and are supplied sterile. Disposable suction and air/water help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The subject devices are easily incorporated into infection prevention policies as a single use item. The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image. while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures. The suction and air/water are housed together with biopsy valve and auxiliary water connector in a single tray and packaged in sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate device.

The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The biopsy irrigator is intended to cover the endoscope biopsy port for sealing and endoscopic device passage/ exchange, at the same time use in conjunction with irrigation tubing. consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the irrigation tubing. The biopsy irrigator and biopsy valve are packed individually in a sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate devices.