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Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer. The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP. The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.

Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag: - . Infant - Less than or equal to 10 kg - Child less than or equal to 23 kg ● - Adult Greater than 23 kg. ● The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.

Single patient use positive end expiratory pressure (PEEP) valve for use in hospital, transport, emergency, and post hospital care settings to evaluate end lung pressure above atmospheric pressure at the end of exhalation in constant and intermittent gas flow conditions.

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Single patient use adjustable positive end expiratory pressure (PEEP) valves for use in hospital, transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. For use with neonates to adults.

The proposed Galemed Disposable Adjustable PEEP valves are identical to their predicate PEEP Valves, K.082092, except we have replaced some components that were magnetic with nonmagnetic material in order to meet the requirements for MR conditional environments of use. Otherwise the PEEP valves are identical. Galemed disposable adjustable PEEP valves elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation. The Galemed disposable adjustable PEEP valve for use in MR environments is identical to our predicate, K082092, disposable PEEP valve, except we have replaced the materials in 2 components, a push rod and the springs to materials which are less magnetic. Other than these 2 changes, the device is identical to the predicate. These changes / modifications have been evaluated and demonstrated that they do not alter nor change the performance or safety profile of the new device as compared to the predicates.

The B&B Bubbler is intended to provide CPAP, in a hospital environment, to spontaneously breathing neonates and infants < 10 kg who require breathing support due to conditions associated with prematurity or other conditions where CPAP is required or desired and is prescribed by a physician.

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The Pneupac paraPAC plus™ Model 300/310 Ventilators are gas-powered emergency and transport portable ventilators that are primarily intended for use in transport applications in vehicles including fixed and rotary winged aircraft. They are suitable for emergency use at the accident scene, intra and inter-hospital transport and within medical facilities including medical imaging systems to 3 Teslas. They should only be used under the constant supervision of trained healthcare professionals. The devices are intended to provide ventilatory support to adults, children and infants (above approx. 10kg). The devices also provide free flow oxygen therapy and CPAP therapy for spontaneously breathing patients.

The Pneupac® paraPAC plus™ Model 300/310 Ventilators are gas powered portable medical devices intended for the ventilation of adults, children and infants (above approximately 10kg (or 22lb)) during transportation and emergency situations. These models are the enhanced versions of the Pneupac® Parapac® P200D Medic (K020899) gas powered time cycled emergency and transport ventilator which is also one of the predicate devices. Similar to the Pneupac® Parapac P200D, the Pneupac® paraPAC plus™ Model 300/310 Ventilators depend solely on the pressure of the supply gas for their operation. This enables them to be suitable for use in transport applications in vehicles including fixed and rotary winged aircraft. As with the Pneupac® Parapac® P200D, these models also incorporate an integrated electronic pressure alarm unit to alert the user of certain significant changes (such as for high or low inflation pressure) that may occur in patient's ventilation. Loss of battery power for the alarm is signaled to the user, but will have no effect on the performance of the ventilator, nor affect the pneumatically operated alarms and the ventilators functioning. Calibrated frequency and tidal volume controls are color coded to indicate the recommended settings for adults, children and infants. A Positive End Expiratory Pressure (PEEP) control is provided to set PEEP between 0 and 20 cm H2O. It also has a Continuous Positive Airway Pressure (CPAP) control to provide CPAP therapy for spontaneously breathing patients which is also one of the features of the predicate device, the O Two Carevent Systems (K051469). This is achieved by connecting a Pneupac® paraPAC plus™ Disposable CPAP Circuit to the Pneupac® paraPAC plus™ Model 310 Ventilator. An air mix control in the Pneupac® paraPAC plus™ Model 300/310 Ventilators gives FiQ2 option of 0.50 or 1.0. This enables the device to provide a combination of air and oxygen. The Pneupac® paraPAC plus™ Model 300/310 Ventilators use currently available technology found in many legally marketed ventilators. Testing was performed to demonstrate that they are safe and would perform within the environment(s) for which they are to be marketed. The Pneupac® paraPAC plus™ Model 300 Ventilator consists of a control module with user manual, oxygen gas specific standard input hose and a standard disposable patient circuit. The Pneupac® paraPAC plus™ Model 310 Ventilator consists of a control module with user manual, oxygen gas specific standard input hose, standard disposable patient circuit, CPAP disposable patient circuit and hyperinflation bag (K970785). The Pneupac® paraPAC plus™ Disposable CPAP Circuit is an air entrainment device with an attached oxygen and pressure monitoring line for connection solely to the Pneupac® paraPAC plus™ 310 Model Ventilators. The Instructions for Use of the Pneupac® paraPAC plus™ Disposable CPAP Circuit state that it can only be used with the Pneupac® paraPAC plus™ Model 310 Ventilator. As the Pneupac® paraPAC plus™ Disposable CPAP circuit cannot be used without the Pneupac® paraPAC plus™ Model 310 Ventilator, the Pneupac® paraPAC plus™ Disposable CPAP circuit is considered as an integral part of the Pneupac® paraPAC plus™ Model 310 Ventilator for the purposes of this Premarket Notification. The disposable patient circuits provided with the Pneupac® paraPAC plus™ Model 300/310 Ventilators are specifically designed for use with the Pneupac® paraPAC plus™ Model 300/310 Ventilators and the Instructions for Use state that these are the only circuits to be used with the Pneupac® paraPAC plus™ Model 300/310 Ventilators. As the Pneupac® paraPAC plus™ Model 300/310 Ventilators cannot be used without the patient circuit, the patient circuit is considered an integral part of Pneupac® paraPAC plus™ Model 300/310 Ventilators for the purposes of this Premarket Notification.

The PLAXTRON CPAP System is to provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.

The PLAXTRON CPAP System is a state of the art non-invasive, disposable ventilator support system. It is a venturi type oxygen / air mixture delivery device which provides CPAP pressure with a 50 PSI compressed gas source at a low input flow to a spontaneously breathing patient. The controlled airway pressure provides rapid relief for maximum patient benefit with minimal oxygen consumption. The device is low cost and completely disposable for single patient use and it is highly efficient to run from a low flow source for longer cylinder life. It equips with filters on inhalation and exhalation to provide maximum protection.

o two CPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients in the hospital environment and emergency medical service applications to treat patients in respiratory distress.

The o two CPAP device provides a constant positive airway pressure to the lungs of patients in respiratory distress from Pulmonary Emphysema, Congestive Heart Failure and a number of other obstructive airway conditions. This open system has no moving parts and uses a "vectored flow valve" to create a wall of resistance to expiration and an additive flow to inspiration. By varying the oxygen flow through the valve the baseline pressure can be raised or lowered to maintain a positive airway pressure. The rise in baseline pressure keeps alveoli from collapsing, forces fluid in the lungs back intro the interstitium and improves medication delivery.

The WaterPAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.

The WaterPAP Valve is an infant positive end expiratory pressure device used to increase end lung pressure above atmospheric in constant flow conditions.

The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients < 10Kg.

The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.

The VentStar Resuscitaire CEU with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability. The valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The VentStar Resuscitaire CEU is a disposable breathing circuit for the transmission of breathing gases from a breathing gas source (Resuscitation Module) to the newborn patient in labor and delivery environments. It is suitable for newborn patients from birth to 1 month of age (maximum body weight of 10 kg (22 lb)). It is intended exclusively for use in combination with the Resuscitaire Radiant Warmer. The VentStar Resuscitaire CEU is a prescription device.

The VentStar Resuscitaire CEU with PEEP valve is indicated as accessory to add positive end expiratory pressure breathing capability. The valve is designed into the T-Piece of the breathing circuit with a standard fitting for face mask, laryngeal mask or endotracheal tube.