21 CFR § 880.5570 General Hospital and Personal Use Devices

§ 880.5570 Hypodermic single lumen needle.

Current through Sep 8, 2026 · Read all of Part 880

(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).

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