Siemens Healthcare Diagnostics Products GmbH L2KPM IMMULITE 2000/XPi Probe Cleaning Kit

The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems.Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems.Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The VivaScope 2500 is an IVD confocal microscope that produces enlarged images of fresh or fixed specimens, in reflectance (phase contrast) mode, or in fluorescence mode for specimens that are stained with fluorochromes that fluoresce when illuminated with a laser. The VivaScope 2500 is used by physicians and other licensed healthcare professionals to view enlarged images of specimens during pathological examinations.

Self-curing composite material for the fabrication of provisional crowns and bridges.This kit contains a cartrige 50 ml A2, dispenser type 2 and accessories.

The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems.Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems.Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.