A battery-powered device intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep a...
A radiation protection device intended for hospital or clinic use that is specifically designed to shield persons from unintended radiation exposure to radioactive materials, sources, devices, and/or radiopharmaceuticals that are being kept in the facility....
A battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the dia...
An assembly of battery-powered devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating arthritic tissue in a joint across the skin (tran...
A non-sterile insulated metal wire(s) designed to conduct electrical signals between neuromuscular transmission (NMT) electrodes and sensors placed on a patient's body and a patient monitoring system module, intended for the monitoring of patient relaxation...
A device designed as a container to allow the safe deposit, collection and storage of radioactive materials including containers previously used for those materials (e.g., scintillation vials). This container consists of a metal and/or hard plastic disposab...
An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electri...
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of uncarboxylated matrix Gla-protein (ucMGP) in a clinical specimen, using a chemiluminescent immunoassay method. This test is typi...
An electro-optical device intended to noninvasively measure zinc protoporphyrin (ZnPP) in a patient’s red blood cells to screen for conditions related to increased levels, such as iron deficiency or lead poisoning. It consists of a software-assisted spectro...