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The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.

The FilteredFlo warming blankets are used with the IOB Temperature Management System (previously cleared k231596) that draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the FilteredFlo Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The FilteredFlo warming blankets in the submission are the following: FF-243 ADULT/PACU BLANKET FF-244 PEDIATRIC BLANKET FF-246 INFANT UNDERBODY BLANKET FF-247 LARGE PEDIATRIC UNDERBODY BLANKET FF-248 ADULT UNDERBODY BLANKET FF-443 UPPER BODY BLANKET FF-442 LOWER BODY BLANKET FF-344 TORSO BLANKET FF-145 WARMING TUBE BLANKET These blankets are single-use and disposable. Each blanket consists of two layers of nonwoven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The IOB Temperature Management System Model IOB-507 is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

The IOB Temperature Management System Model IOB-507 consists of the IOB Warming Unit and the IOB Warming Blankets. The IOB Warming Unit, model IOB-507, draws ambient- temperature air through a 0.2 micron air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The warming unit has three temperature settings of 32℃, 38℃, and 43℃. These temperature settings are servo-controlled by a thermistor placed at the end of the hose where the hose connects to the blanket. The unit can also deliver ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the average contact surface temperature of the blanket. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the unit to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow options. A safety thermistor provides a signal to a separate high-temperature analog circuit. The safety thermistor activates and produces an alarm if the temperature exceeds the set point. The analog safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures. IOB warming blankets are single-use and disposable. Each blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The IOB Warming Blankets are indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

The IOB warming blankets are used with the IOB Temperature Management System (previously cleared k162679) that draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. These blankets are single-use and disposable. Each blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The ivi N3003 Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile. The ivi N6006 Surgical Mask is single-use, disposable device, provided non-sterile, and intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

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The IOB Warming Blankets are indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

The IOB warming blankets are used with the IOB Temperature Management System (previously cleared k162679) that draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient.. The IOB Warming Blankets in this submission are the following: Jackson Warming Blanket IOB-024 Infant Full Body/Under Body Blanket IOB-025 Large Half Body Blanket IOB-026 Large Full Body Blanket IOB-027 Infant Under Body Blanket IOB-028 Lithotomy/Orthopedic Under Body Blanket IOB-029 Small Size Warming Suit IOB-301 Medium Size Warming Suit IOB-302 Large Size Warming Suit IOB-303 Extra Large Size Warming Suit IOB-304 These blankets are single-use and disposable. Each blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The IOB Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

The IOB Temperature Management System consists of the IOB warming unit and the IOB warming blankets. The IOB warming unit draws ambient- temperature air through a 0.2 micron air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The warming unit has three temperature settings of 32°C, 38°C, and 43°C. These temperature settings are servo-controlled by a thermistor placed at the end of hose where the hose connects to the blanket. The unit can also delivers ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the blanket at the end of the hose. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow for choose. The IOB Warming Blankets in this submission are the following: Torso IOB-001 Lower Body IOB-002 Upper Body IOB-003 Full Body IOB-004 Pediatric Underbody IOB-005 Adult Underbody IOB-006 Pediatric Full Body IOB-007 Full Body Surgical IOB-008 Large Pediatric Underbody IOB-009 Spinal Underbody IOB-010 Lithotomy Underbody IOB-011 Pediatric Lower Body IOB-012 Pediatric Long IOB-014 Cath Lab IOB-015 Surgical Access IOB-016 Chest Access IOB-017 Multi-Access IOB-018 Dual Port Torso IOB-019 Cardiac Access IOB-020 XL Upper Body IOB-021 Outpatient Care IOB-022 Cardiac IOB-023 These blankets are single-use and disposable. Each blanket consists of two lavers of non-woven polypropylene fabric coated with a layer of polyethylene. The lavers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.

The IOB disposable vaginal speculum consists of up and under plastic blades and handle with three different sizes (smail, medium and large). The speculum is used by medical professionals to visualize interior of vagina and cervix during patient examination.