Identification. An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 876.9.

Oxygen Cannula has an oxygen inlet flowably connectable to an oxygen supply, two neck tubes and oxygen delivery tubes. Oxygen cannulas are designed to deliver oxygen from an oxygen source to the nostrils at the prescribed rate determined by the healthcare giver.

An Oxygen Filter System is for preventing the transmission of a disease from a patient to medical personnel. The oxygen mask filter system includes a face mask having an interior surface and an exterior surface, a plurality of vent apertures, a disk member movably attached to the exterior surface of the face mask about the vent apertures and a filter member attached to the interior surface of the face mask for filtering gases prior to expulsion from the interior of the face mask to the exterior through the vent apertures.

An Oxygen Flowmeter System provides a flow of oxygen to the patient undergoing anesthesia in the event of a detected fault in the overall supply and mixing system of the anesthesia system. The normal design of such supply and mixing systems for an anesthesia system provides oxygen and at least one other gas that are mixed together in a desired proportion to be provided to a vaporizer and then to the anesthesia system as fresh gas. In the present system, a processor continuously monitors the output flows from those proportioning mixing valves. When the processor determines that those flows from the proportioning valves are off by a predetermined amount, indicative of a fault in the system, the processor immediately shuts off the supply of any gases other than oxygen and also provides a flow of oxygen to a bypass line that bypasses the oxygen proportioning valve, thus assuring a supply of oxygen to the patient despite the fault. A manual valve may be included in the bypass line so that the clinician can control the flow of oxygen and a flowmeter is provided so the clinician can visually note the flow and control that flow accordingly.

Oxygen Humidifier provides high humidity to oxygen using the bubble-type humidification process. It contains a 2-psi safety relief valve, an O2 DISS female nut inlet fitting and a removable diffuser head. Oxygen humidifier includes the jar, lid assembly, sealing gasket and diffuser.

Oxygen Therapy kit is used in emergency, transport, clinic or home use. It features robust construction of steel trolley, powder coated finish and available in pre-configured kits with 12 cft, 24 cft, & 48 cft cylinders. The kit is available with a 15 LPM diaphragm regulator for both 'E' and 'H' cylinders.

An Oxygen Connector System for coupling an oxygen source to an oxygen tube comprises a source of oxygen. The source has an output orifice through which source oxygen is adapted to pass. The orifice has an inner bore and an outer surface. A flexible cylindrical elastomeric tube has a first input end and a second output end. The first input end is adapted to make a flush abutment with the source at the orifice. A generally cylindrical rigid connector has an exterior surface with a first region and a second region. An intermediate tapered region is provided between the first and second regions. The connector has a central generally cylindrical bore extending through the first and second ends forming an interior surface. The second end has a diameter slightly greater than that of the tube. A pair of stoppers are provided adjacent to the input end of the tube.

Ozone Generators produce a continuous flow of ozone as well as a stable source for water purification and air pollution studies. It is designed for calibration of field and laboratory ozone analyzers. Typical ozone generators include continuous ozone output indication & control, built-in safety monitoring subsystem & interlocks, VCR fittings, cooling water leak detector and freestanding rack cabinet enclosure.