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Non-invasive - Handle or modify substances for administration to a patient
Body
Devices in this category are primarily intended to:
- channel or store blood or body liquids that will be infused, administered, or introduced into a patient, or
- store an organ, part of an organ or body tissue that is to be later introduced into a patient (this includes containers and any liquids, gels, or other storage media), or
- channel or store a liquid or gas that is to be infused, administered, or introduced into a patient (this includes devices that may be connected to an active medical device that is Class IIa or higher), or
- modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, only by filtration, centrifugation or exchanges of gas or heat.
- modify the biological or chemical composition of blood, other body liquids, or other liquids intended to be infused into a patient, by any means other than filtration, centrifugation or exchanges of gas or heat.
Examples of devices in this category:
Drug delivery systems, breathing circuits, syringes for infusion pumps, devices intended for storage of organs or tissues for transplantation (this includes containers and any liquids, gels or other storage media), refrigerators intended for storing blood, hemodialysis machines, devices used for particulate filtration of blood in an extracorporeal circulation system, centrifugation of blood for transfusion or autotransfusion, removal of carbon dioxide from the blood and/or adding oxygen, and warming or cooling blood in the extracorporeal circulatory system.
Question
Based on the above, what is the intended purpose of your device?
Answers