21 C.F.R. § 880.5570

Current through September 30, 2024
Section 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).

21 C.F.R. § 880.5570