D C54577 CDRH Component Code Terminology C60828 Safety The state of being certain that adverse effects will not be caused by some agent under defined conditions. Safety 4751 Safety related component. IMDRF:G06 D C54577 CDRH Component Code Terminology C81182 Measurement Device Any device used to determine the dimension of an object. Measurement 4714 Component capable of measuring something in order to obtain a result. IMDRF:G03 D C54577 CDRH Component Code Terminology C16940 Optics The branch of physics that describes the behavior and properties of light and the interaction of light with matter. Optical 4748 Component which involves or relates to vision, light, or images. IMDRF:G05 D C54577 CDRH Component Code Terminology C171341 Biological and Chemical Component Component whose mode of action involves a biological process (e.g. test strip which acts on antibodies) and chemical reaction or transformation (e.g. activated charcoal absorber). Biological and Chemical 4701 Component whose mode of action involves a biological process (ex. test strip which acts on antibodies) and chemical reaction or transformation (ex. activated charcoal absorber). IMDRF:G01 D C54577 CDRH Component Code Terminology C171972 Electrical and Magnetic Component Components which relate to the force of magnetism or such as microchips and transistors which control and direct electric currents. Electrical and Magnetic 4704 Components which relates to the force of magnetism or such as microchips and transistors which control and direct electric currents. Also includes components involved in the representation, storage, or transmission of information by electronic systems. IMDRF:G02 D C54577 CDRH Component Code Terminology C172006 Mechanical Component A device that is designed to be part of a machine. Mechanical 4719 Component of a device when it is working, often using power from an engine or from electricity. IMDRF:G04 D C54577 CDRH Component Code Terminology C17649 Other Different than the one(s) previously specified or mentioned. Others 4754 Other (COT/POT/OM) || Terms not yet classified. If these terms get moved to other categories, this category can be deleted. (Previously the device category) IMDRF:G07 D C54450 CDRH Health Effect - Clinical Code Terminology C50537 Distention The condition of being stretched beyond normal dimensions. Abdominal Distention 2601 The condition of the abdomen being enlarged or swollen from internal pressure. IMDRF:E1001 N C54577 CDRH Component Code Terminology C172788 Semiconductor A type of electronic component that makes use of the variable conductivity of certain materials. Semiconductor 4763 A type of electronic component, including transistors and diodes, that make use of the variable conductivity of certain materials. IMDRF:G0201207 N C54577 CDRH Component Code Terminology C172789 Touchscreen A control component that operates an electronic device by pressing the display on the screen. Touchscreen 4764 A control component that operates the device following pressing the display on the screen. IMDRF:G0204004 N C54577 CDRH Component Code Terminology C172790 Cuvette A clear container designed to interface with an optical sensor in order to obtain an optical measurement of a contained substance. Cuvette 4765 A clear container designed to interface with an optical sensor in order to obtain an optical measurement of a contained substance. IMDRF:G03006 N C54577 CDRH Component Code Terminology C172792 Bellows A component that expands and contracts to draw in air through a valve or orifice and expels it through a tube. Bellows 4766 A component that expands and contracts to draw in air through a valve or orifice and expels it through a tube. IMDRF:G04012 N C54577 CDRH Component Code Terminology C172793 Clutch A component that engages and disengages power transmission. Clutch 4767 A component that engages and disengages power transmission. IMDRF:G04028 N C54577 CDRH Component Code Terminology C172794 Coating Material A layer of material covering the surface of a device. Coating Material 4768 A layer of material covering the surface of a device. IMDRF:G04029 N C54577 CDRH Component Code Terminology C172795 Device Collapser A component designed to fold or collapse something. Device Collapser 4769 A component designed to fold or collapse something. IMDRF:G04043 N C54577 CDRH Component Code Terminology C172796 Fabric Cloth produced from textile fibers. Cloth 4770 Cloth produced from textile fibers. IMDRF:G04050 N C54577 CDRH Component Code Terminology C172797 Lever A rigid bar that rotates around a fixed point. Lever 4771 A rigid bar that rotates around a fixed point. IMDRF:G04082 N C54577 CDRH Component Code Terminology C172798 Potting The resin, glue or other substance used to seal other components together. Potting 4772 The resin, glue or other substance used to seal other components together. IMDRF:G04101 N C54577 CDRH Component Code Terminology C172799 Rachet A device part that allows or forces another part's movement in a single direction. Rachet 4773 A part that allows or forces another part's movement in a single direction. IMDRF:G04107 N C54577 CDRH Component Code Terminology C172800 Tool A component that is not part of a device but is designed to support its assemby or operation. Tool 4774 A component that is delivered with a device to support its assemby or operation, and is not part of the device. Use only in the case there are no other terms to describe the component. IMDRF:G04130 N C54577 CDRH Component Code Terminology C172801 Translational Motion Component A rotating part of a device which is intended to transfer rotational movement or motion to another type of movement. Translational Motion Component 4775 A rotating part which is intended to transfer rotational movement or motion to another type of movement (e.g. excenters). IMDRF:G04131 N C54577 CDRH Component Code Terminology C50126 Pulley Device A wheel with a groove in it designed to change the direction of force of a rope or belt that runs over it. Pulley 923 IMDRF:G04104 N C54577 CDRH Component Code Terminology C50129 Compressor Air Pump Device A pump designed to facilitate the movement or compression of air. Compressor 557 A component that increases the pressure of air or gas. IMDRF:G04036 N C54577 CDRH Component Code Terminology C50175 Shutter Device A mechanical or electronic device designed to regulate an exposure time, especially the one in a camera. Shutter 960 Aperture that controls or blocks light or radiation passing through. IMDRF:G04142 N C54577 CDRH Component Code Terminology C50237 Capillary Tube Device A tube with a narrow diameter designed to hold a liquid by capillary action. Capillary Tube 587 A narrow tube in which a liquid flows up against gravity. IMDRF:G0413401 N C54577 CDRH Component Code Terminology C50262 Vaporizer Device A device designed to convert a solution to an aerosol or mist, especially one to prepare a medication for inhaling. Vaporiser 543 A component for gasifying liquids such as drugs. IMDRF:G04136 N C54450 CDRH Health Effect - Clinical Code Terminology C78161 Abdominal Distension Swelling of the abdomen resulting from excessive food intake, malnutrition, liver disease, primary abdominal tumors, and tumors metastatic to the abdominal cavity. Abdominal Distention 2601 The condition of the abdomen being enlarged or swollen from internal pressure. IMDRF:E1001 C C54450 CDRH Health Effect - Clinical Code Terminology C50683 Device Overstimulation A level of stimulation delivered by a device that is greater than the intended level. Device Overstimulation of Tissue 1991 A level of stimulation that is greater than the intended level. IMDRF:E2103