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The demand valve is used for the application of 100 vol% oxygen during manual ventilation with the resuscitator bag, as well as during direct non-invasive inhalation with the resuscitator mask in spontaneously breathing patients.

The valve, non - rebreathing QualityFlow O2 demand valve is a medical device to deliver medical oxygen or a medical air - oxygen mixture to a patient on demand. Unlike continuous oxygen systems, the demand valve only supplies medical gas when the patient inhales, reducing oxygen consumption and ensuring the patient receives gas only when needed. The QualityFlow O2 Demand Valve from DEHAS consists of a membrane that is activated by negative pressure during inspiration and a valve mechanism that controls gas flow. During inspiration, the valve opens due to the movement of the membrane, while during expiration it is closed by a return spring. The function of the demand valve is based on providing gas only when a negative pressure is applied to the membrane, e.g. by the patient inhaling with a connected mask or suction of the resuscitator when connected (expansion after previous compression of the resuscitator). The valve therefore ensures that gas only flows when it is needed.

This product is intended for use as an in-line pressure relief device, designed to limit the system pressure within the limits of its stated technical specifications. This product is indicated for patients in a hospital for use by appropriately qualified healthcare professionals.

The F&P Optiflow Flow Diverter is intended for use as an in-line pressure relief device, designed to limit the system pressure when used with the compatible F&P Optiflow Oxygen Kits and nasal interfaces. The F&P Flow Diverter is placed between the flow meter and the dryline during use. It is a multi-patient use prescription-only device, provided in a non-sterile state. It operates at flow rates between 5 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals. When an anesthesia mask is applied over the Optiflow Switch interface, the respiratory gas no longer has a pathway to flow through the nasal interface to the patient. This will trigger respiratory gas flow to be diverted into the atmosphere.

The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached. The single limb model directs flow and allows for pressure monitoring and may be used within hospitals and for home care use. The dual limb model regulates flow and is for use in hospitals and for home care use. The exhalation valve are used with adults, pediatrics, and neonates. The exhalation valves are for single patient use and can be used for a maximum of 30 days.

The Altech® Exhalation Valves (Single Limb) are available in 2 configurations intended for use in Single and Dual Limb ventilator circuits. The difference between the configurations is location of exhaust of the expired gas to the room. In the Single limb, the valve is integrated to the limb and expired gas exhausts through the opening below the valve whereas in the valve is attached to the end of the exhalation limb and the expired gas exhausts through device end of the valve.

This device is used as a physical barrier for mouth to mouth resuscitation. The use of this device does not guarantee complete protection from disease transmission.

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The OJR215 Pressure Relief Manifold is designed to protect neonates, infants and children from excessive inspiratory pressure in the event of a downstream occlusion occurring in continuous flow breathing gas delivery systems via nasal cannula. The device is intended for use with flow rates greater than 0.5 L/min up to, and including. 36 L/min. The OJR215 is fitted upstream of the patient. The OJR215 is single use only and is prescription only.

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ClearMate™ is intended to be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate" enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing.

This device is intended to induce isocapnic hyperventilation in patients to speed up elimination of carbon monoxide (CO). Isocapnic hyperventilation can be defined as large increases in patient minute volume with minimal changes in arterial partial pressure of carbon dioxide (CO2). This device replaces CO2 levels in the airway, thereby maintaining CO2 levels in the blood that ultimately causes hyperventilation. This pneumatic device initially provides 100% supplemental oxygen (O2) at minute volumes selected based on patient weight. If the patient minute volume demand is more than the preset supplement O2 volume, this device supplies a mixture of 94%/6% (O2/CO2), which maintains CO2 levels in the airway to enable isocapnic breathing by partial simulated rebreathing (of CO2). This device consists of: 1. The subject of this De Novo, the Control unit ("briefcase"), connects to sources of O2 and CO2 (neither gas is supplied with this device). The unit includes pressure gauges to read the source gas pressures. Internal components control supplemental gas flowrates, gas concentrations, and CO2 diversion away from the gas delivery pathway should O2 pressures be insufficient. This unit weighs about 2 kg and is pneumatically driven (i.e., no electronics). 2. Two breathing circuits, which are not the subject of this De Novo, can attach to the gas outlet ports of the control unit. These circuits are constructed of reservoir bags (21 CFR 868.5320, Class I), oxygen cannulas (21 CFR 868.5340, Class I), masks (21 CFR 868.5550, cleared under K953107), valves (21 CFR 868.5870, cleared under K142402), resuscitation bags (21 CFR 868.5915, cleared under K912203), and/or tubing (21 CFR 868.5925, cleared under K161420). 3. Hoses for source gas connections and a device stand for steadying the device, which are a subject of this De Novo.

The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use. The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask without Oxygen Port is intended for over-the-counter use. The Infant CPR Mask without Oxygen Port is designed to provide immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The Infant CPR mask is indicated for use on infants with body weight up to 10 kg (22 lbs). The Infant CPR Mask is intended for over-the-counter use. The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use.

Compower Emergency CPR masks with non-rebreathing valves are designed to assist in providing immediate life support to health emergency victims requiring oxygen support and cardiopulmonary resuscitation rescue techniques. The devices subject to this 510(k) include the following: CPR Mask with Oxygen Port, CPR Mask without Oxygen Port, Infant CPR Mask without Oxygen Port, Non-Rebreathing Valve (15mmOD), Non-Rebreathing Valve (18.5mm). CPR Mask with Oxygen Port: comprised of an air cushion, foldable mask cover with oxygen port, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only. CPR Mask without Oxygen Port: comprised of an air cushion, foldable mask cover, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only. Infant CPR Mask without Oxygen Port: comprised of an air cushion, mask cover and non-rebreathing valve. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only. Non-Rebreathing Valve: a non-sterile, single-use device designed with a rigid styrene-butadiene copolymer housing, a silicone valve plate and polypropylene filter. Compatible for use with 22mm connectors used in standard ventilation masks. Designed with 15mmOD and 18.5mm ports.

The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation ("CPR") rescue techniques. It is intended for over-the-counter use.

The Seal Rite™ Non-Rebreathing Valve ("Seal Rite Valve") is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the grooved patient end that will adapt to standard masks (22 mm ID) used for resuscitation. The Seal Rite Valve allows the rescuer to blow air into a mask through its silicone one-way valve and directs the patient's exhaled air away from the rescuer via a rigid one-way valve and multiple exhaust ports. The Seal Rite Valve helps protect the rescuer from potential patient contamination. The Seal Rite Valve does not have an oxygen port.

The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use. The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring cardiopulmonary resuscitation (CPR) resuscitator without oxygen port is for overthe-counter use.

The KYOLING CPR mask is used during cardiopulmonary resuscitation procedures, which are used in emergency situations to supply oxygen and produce blood flow in the heart and lungs. The CPR mask is made of PVC and one-way valve made of medical grade K-resin, the mask is used for mouth-to-mask breathing, it provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with the unknown subject; and also it promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. The KYOLING CPR Mask includes transparent dome, universal breathing tube, one-way filtered valve, head strap, and with Oxygen Port or without Oxygen Port.

The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.

The BigEasy™ Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the patient end that will adapt to standard masks (22mm ID) or endotracheal tubes (15mm OD) used for resuscitation. It provides a path for a rescuer to blow expired air into a mask or endotracheal tube through a silicone valve in the device and has a rigid one-way valve that directs exhaled air from the patient away from the rescuer. It also incorporates an oxygen inlet port on the rescuer's side of the valve for the adding of supplemental oxygen without requiring a separate adapter.