(174 days)
The BIO-PLEXUS™ Needle Disposal Container is to be used by healthcare workers in healthcare facilities and in the home healthcare setting for the disposal of contaminated PUNCTUR-GUARD® needles and accessories.
The BIO-PLEXUS™ Needle Disposal Container is a single use, one quart, puncture resistant container comprised of a bucket like base and an affixed cover. The bucket and the cover are plastic injection molded from polypropelene. The cover has three openings and two hinged lids.
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§ 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).