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To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: - Keeping the suitable depth of endoscope's view field - Helping the endoscope with being inserted into the gastrointestinal tract

The subject device is a sterile, single use, disposable medical device. It is designed to be placed on the distal end of an endoscope during endoscopic procedures to improve the physician's ability to visualize and examine the mucosa. AmplifEYE is made of injection molded polymer and consists of a main body tube with flexible wings arranged in a single row around one end of the main body tube. In a standard colonoscopy procedure, the endoscope is intubated through the rectum and advanced forward through the length of the colon. The endoscope is then retracted while the physician visually examines the colon mucosa for polyps or other abnormalities. The AmplifEYE wings fold down during intubation and movements that advance the endoscope forward so that forward movement is not hindered. During endoscope withdrawal, the wings open and fold outward to keep the depth of the endoscope's view field by manipulating the colonic folds and stabilizing the position of the endoscope within the intestinal lumen, thus aiding in the physician's ability to visualize and examine the mucosa.

The DEFENDO Disposable Suction Valve is intended to be used to control the suction function of a compatible bronchoscope during a pulmonary procedure.

The subject device is a sterile, single use, disposable medical device. It is designed to be attached to the suction port of a bronchoscope during a pulmonary procedure to help the user engage in the suction function of the bronchoscope by depressing/activating the valve. The activation of the suction valve allows the user to control the suction flow of fluids from the patient to a suction pump/waste canister.

Minncare HD is intended for the disinfection of water purification systems for hemodialysis. It should be diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and used for a minimum contact time of 36 minutes at 20°C.

Minncare HD is a clear liquid disinfectant solution that consists of a stabilized mixture of hydrogen peroxide, peracetic acid and acetic acid. Minncare HD is intended to be used for hemodialysis water purification system disinfection when diluted to a 1% concentration (1 part Minncare HD to 99 parts water) and applied for a minimum contact time of 36 minutes at 20℃. The active microbicidal ingredient is peracetic acid (PAA), and the recommended use concentration of 1%. The concentration of the use solution should be confirmed with 1% Minncare HD indicator test strips to have reached the furthest point of the distribution loop during the system disinfection contact time. Upon completion of disinfection the system must be rinsed to remove residual levels of the disinfectant. Residual levels should be checked using Minncare HD residual test strips to ensure residual levels of 1 ppm PAA or less. Minncare HD is supplied in cases containing high density polyethylene plastic bottles. Individual bottles are labeled with all information necessary to use the device safely.

Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated sterilization of clean, heat sensitive, critical medical equipment for which alternative methods of sterilization are not suitable. Critical medical devices are those that contact normally sterile areas of the body. Critical medical devices must be sterilized. Rapicide™ High Level Disinfectant and Sterilant is a sterilant when used or reused, in a legally marketed Automated Endoscope Reprocessor according to Directions for Use, at a minimum recommended Concentration (MRC) of 1.5% glutaraldehyde at 35℃ (95°F), not to exceed 28 days, with a minimum contact or immersion time of at least 7 hours and 40 minutes. Rapicide™ High Level Disinfectant and Sterilant is intended to be used for the automated high level disinfection of clean, heat sensitive, semi-critical medical devices for which sterlization is not practical. Semi-critical medical devices may be sterilized or high-level disinfected. Semi-critical medical devices are those that contact mucous membranes or other body surfaces not normally considered sterile. Rapicide™ High Level Disinfectant and Sterilant is a high-level disinfectant when used or reused, in a legally marketed Automated Endoscope Reprocessor according to Directions for Use, at a minimum recommended concentration (MRC) of 1.5% glutaraldehyde at 35°C (95°F), not to exceed 28 days, with a minimum contact or immersion time of at least 5 minutes.

Rapicide™ High Level Disinfectant and Sterilant is a ready-to-use solution with an active ingredient of 2.5 ± 0.1% w/v qlutaraidehyde, with a slightly acidic pH value of 6.3 to 6.7. The patented formulation (U.S. Pat. Reg. No. 4,748,279) includes a non-ionic detergent for improved wetting of surfaces. The glutaraldehyde concentration is stabilized by means of a buffer to pH 6.3 to 6.7. Other formula ingredients include a corrosion inhibitor, silicone antifoam chemical, and dyes. The formula is about 90% purified water. The ingredients of Rapicide™ High Level Disinfectant and Sterilant are similar to those in the predicate, Wavicide-01 Solution.