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The POGS 65/130 is intended to generate and deliver USP 93% supplemental oxygen. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, military settings or where bottled oxygen is not readily available.

The Portable Oxygen Generation System 65/130 (POGS 65) has been designed to accommodate medical personnel that require a portable, reliable source of supplemental oxygen in a setting where liquid oxygen may be unavailable. This system is based on the Pressure Swing Absorption principle and uses a molecular sieve to separate gasses from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through the oxygen boost and distribution system. The POGS 65/130 is a system that generates USP 93% oxygen at a flow rate of up to 65 LPM at a pressure of 50-60 PSI. Included with the generator are medical-grade oxygen hose for both low and high pressure, spare parts and tools that are required, but may be not be easily accessible to the user. The POGS 65/130 is compatible with commercial oxygen consuming equipment and accessories, including D. E, H, K, and M cylinder filling accessories, ventilators, nasal cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators. It also connects with the high pressure Hospital Oxygen Backup System and the low-pressure Patient Oxygen Distribution System. A complete POGS 65/130 system consists of two (2) feed air compressors, two (2) oxygen generators, one (1) boost and distribution center, and one (1) oxygen back-up system. Each feed air compressor and oxygen generator pair is designed to provide up to 65 LPM independently or can operate in parallel to achieve up to 130 LPM to provide the user flexibility in the deployment of their resources. The approach is modular and enables the user to add or subtract systems to meet the requirements of the situation. Each POGS 65 pair responds to the oxygen demand that is being used and when operated in parallel, will load share between the pair. The boost and distribution system receives the oxygen from up to two oxygen generators. The boost and distribution system can feed the oxygen to 1) the hospital distribution system, 2) fill the back-up system, 3) fill cylinders or 4) fill the hospital back-up system depending upon the requirements of the situation. To ensure patient care, the hospital distribution system has priority over all other options. One or more type of cylinder or back-up system may be filled in conjunction with supplying the hospital distribution system. The System includes the capability to evacuate high pressure oxygen cylinders to 25 inches Hg vacuum prior to filling.

The POGS 33C is intended to generate and deliver USP 93% supplemental oxygen and medical grade air. This device is intended to be used only by trained personnel in disaster relief and emergency preparedness situations, or military settings where bottled oxygen is not readily available.

The Portable Oxygen Generation System 33 (POGS 33C) has been designed to accommodate medical personnel with a source of supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment. Aero-medical evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. Requirements are based on the mobile, deployment oxygen system, operational requirements document that has been issued by the United States Air Force. This system is based on the Pressure Swing Absorption principle and uses a molecular sieve to separate gasses from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of four ports with a total maximum flow of 33 liters-per-minute at 50 PSIG. The oxygen concentration purity level is at 90% +/- 3%. Included with the generator is a secured accessory kit including medical-grade oxygen hose and flow regulators for the outlets. The POCS 33C is compatible with commercial oxygen consuming equipment and accessories, including D, E, H, and K cylinder filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators. Medical air output of up to a total of 30 liters-per-minute at 50 PSIG is also provided.

The POGS 33C is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. The POGS 33C is compatible with commercial oxygen-consuming equipment and accessories, including D, E, H, and K cylinder-filling accessories, ventilators, cannulas, Draeger Narkomed Anesthesia machines and Impact Univent/Eagle 754/754M Ventilators.

The Portable Oxygen Generation System 33 (POGS 33C) has been designed to The Fortable Oxygen Ocheration of Supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment. liquid oxygen may be unavaliable, and sed medical missions require medical support systems Aeromedical evacuation and ground ban. The gaseous oxygen generator will also be required Capable of providing therapoule oxygen. The gassessing and the oxygendriven equipment included in the AFMS deployable medical assemblages. Requirements are differi equipment included in the uspicy and mational requirements document that has been issued by the United States Air Force. This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of four ports with a total maximum flow of 33 liters-per-minute at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit including medicalgrade oxygen hose and flow regulators for the outlets. Medical air output of up to a total of 30 liters per minute at 50 PSIG is also provided.

The POGS is intended to provide medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only. POGS is compatible with commercial oxygen-consuming equipment and accessories, including D,E,H, K cylinder-filling accessories, ventilators, cannulas, and Draeger Narkomed Anesthesia Machine.

The FDA-cleared On Site Gas Systems' Portable Oxygen Generation System 33, "POGS 33", (K020362) is being modified to include medical air, and compatibility with the Draegar Narkomed Anesthesia Machine. The system uses PSA technology, and supplies medical grade air and oxygen (USP oxygen 93%) at 50 PSIG nominal and lower output pressures in battlefield/ hospital settings in military facilities only. The POGS 33 utilizes the same Draegar Narkomed Anesthesia Machine as the predicate, PVOCS. The POGS 33 utilizes the same oilless scroll feed compressor in the production of medical air as does the predicate, PVOCS. The variations of the POGS device to the predicate are greater oxygen total flow, to accommodate more cannulas per device. The variations are designed and tested for the same indication of use, safety and effectiveness. Variations are substantially equivalent to the predicate device.

Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

Hemosorb is a bulk granular hemostatic agent, which is placed on or into a wound to effect adsorption, and coagulation of same. The effect of Hemosorb is purely physical, not chemical in nature. Hemosorb has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.

QuikClot is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

QuikClot is a bulk granular hemostatic agent, which is placed on or into a moderate to severe wound to effect adsorption, and coagulation of same. QuikClot is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss. The effect of QuikClot is purely physical, not chemical in nature. QuikClot has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation. Used in conjunction with a sterile bandage and pressurizing wrap, QuikClot will reduce blood loss dramatically, and significantly increase survivability of highvolume catastrophic wounds.

The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.

The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxygen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen. The variations of the device are to allow for less total flow, to accommodate fewer cannulas per device. The variations are designed and tested for same indication of use, safety and effectiveness; variations are substantially equivalent to predicate devices.

The POGS is intended to provide supplemental oxygen. Device is to be operated by trained medical personnel only for military use only.

The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of The feed air compressor creates a vacuum to draw air into a oxvaen. holding talk. The air is then flushed through two tanks in series to provide continuous oxygen. The molecular sieve material adsorbs nitrogen, which comprises approximately 78% of the makeup of air. The resulting gas is approximately 93% oxygen.