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Title 21 Part 880 → Subpart F → §880.5725

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5725

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5725

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5725


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices


§880.5725   Infusion pump.

(a) Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

(b) Classification. Class II (performance standards).


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