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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 Gio Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratory care devices used in the hospital, and post hospital environments. It may be attached by flexible tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.

The Gio Digital Manometer is light, portable, accurate and can be operate by one hand, monitoring airway pressure during respiratory care. The digital display facilitates easy reading of the pressure value. The manometer displays pressure values on the front panel both digitally and on an analog bar scale. The Gio Digital Manometer also provides a function that display peak pressure when the right button is pressed and the P&H function is activated. The Gio Digital Manometers are available in four different pressure ranges. All four manometers utilize the same mechanism and only differ in their pressure detecting ranges.

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: <= 10 Kg, Child: <= 23 Kg, Adult: > 23 Kg 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: <= 10 Kg, Child: <= 23 Kg, Adult: > 23 Kg This manual resuscitator is supplied with 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. Single patient use device for use hospital, transport, emergency, and post hospital care for the elevation of lung pressure above atmospheric pressure at the end of exhalation.

GaleMed DISPO-BAG Manual Resuscitation Bags are disposable, medical devices which temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. GaleMed DISPO-BAG Manual Resuscitation Bags use a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the ventilation bag and includes an oxygen enrichment (reservoir) system. GaleMed Disposable PEEP Valves are disposable medical devices which elevate the pressure in a patient's lungs above atmospheric pressure at the end of exhalation. The GaleMed Disposable PEEP Valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure ranges (5-20 cmH2O and 2.5 - 10 cm H2O) and several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets". Likewise the GaleMed single patient use fixed value PEEP valve is a, spring actuated valve, which when placed into a circuit provides positive end expiratory pressure for the patient. The valve is provided in two pressure settings of 2.4, 5.0, 7.5 and 10.0 cmHzO) also offered in several connector sizes which comply to ISO 5356- I "Anesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets".

The GaleMed CPAP masks are intended to be used in a home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.

The proposed CPAP masks incorporate a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use. - . Full face and Nasal style - . Integral anti-asphyxia valve - Headgear for attachment . - . Single use disposable and Single patient, multi-use

The GaleMed Model 3751 and Model 3752 peak flow meters are intended to measure a patient's peak expiratory flow. The Model 3751 is intended for use by adults, and the Model 3752 is intended for use by children.

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The GaleMed Neb-Easy Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. It is for adult and pediatric patients.

The nebulizer is a device intended to spray liquids in aerosol form into gasses that are delivered directly to the patient for breathing. It is a Class II device, requlation number: 868.5630. This device operates on the venturi principle and is refillable. The device is called the GaleMed Neb-Easy Nebulizer. It is made from acrylic and polypropylene plastics, is injection molded and is intended for single patient use for up to 28 days. These material types are used in other predicate devices, such as the Salter Labs and Allegiance Airlife product lines. The specific materials have been tested for biocompatibility to ISO 10993 and results showed them to be non-reactive. All testing requirements contained in the "Reviewer Guidance: Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93" have been completed and were submitted by GaleMed for FDA review in their premarket notification submission. Comparative testing data to the predicate device (Allegiance Airlife Misty-Neb, K883964) was also performed at a third party independent test laboratory to the requirements of the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93." The Neb-Easy Nebulizer has several attachments that are used with it during the nebulization process. These include a Tee Connector, which connects to the top of the nebulizer; a mouthpiece and a 6 inch corrugated tube, which connects to the side of the Tee connector opposite the mouthpiece. These are standard accessories to class 1 oxygen masks and breathing circuits as well as being considered standard accessories to a nebulizer devices. A standard oxygen tube connects to the bottom of the Neb-Easy Nebulizer and serves to connect the nebulizer to a pressurized gas source. This gas source is used to create the venturi and high flow conditions inside of the Neb-Easy that are used to create respirable aerosols. Flow rates are determined by the physician, but are typically between 5 lpm and 9 lpm. The accessories, attachments, principles of operation and materials are all essentially equivalent to predicate devices already cleared by FDA.