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The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.

The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The INOblender is designed to take constant oxygen (02) gas flow (5 to 14 L/min) from the integrated O2 flowmeter and blend in NO at the setting on the NO blender's concentration control dial (5 to 80 ppm). The NO blender is calibrated for cylinder concentrations of 800 ppm NO in a balance of nitrogen (N2).

The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.

The INOblender is a Nitric Oxide Administration Apparatus - Back-up System. It provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient.

The FM-1 NO Blender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the FM-1 NO Blender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot be used. In this capacity, it can be used with a self-inflating manual resuscitator bag. This intended use includes applications within a medical facility. The FM-1 NO blender is not intended for use as a primary NO delivery system for long term use. (Note: These indications for use are unchanged form K003665.

The Fadasis Medical FM-1 NO Blender is substantially equivalent to the Fadasis FM-1 NO Blender, The 1 addis Incontaint I 1 1 rith 510(k) premarket notification number K003665. The purpose of this Which was clouded by I DA whan 2000 (EEK, rather than stainless steel, in the capillary tubes. The new FM-1 NO blender is identical to the predicate FM-1 NO blender with the exception of the capillary tube material, which has been changed to PEEK from stainless steel.