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Title 21 Part 880 → Subpart F → §880.5570

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5570

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5570

e-CFR data is current as of January 23, 2020

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5570


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


§880.5570   Hypodermic single lumen needle.

(a) Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

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