(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.
I am sorry, but the provided text describes a medical device, specifically a "Needle Disposal Container," and its intended use. It does not contain any information about clinical studies, performance metrics, acceptance criteria, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as none of that information is present in the input text.
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K960933
Bio-Plexus, Inc. 384 Merrow Road Tolland, CT 06084
CONTACT: Carl R. Sahi (President) March 6, 1996 Prepared:
July 9, 1996 Revised:
Proprietary Name: Generic Name: Classification Name:
Class: Panel Code: Product Code: Reason for submission: Bio-Plexus Inc. Registration Number: BIO-PLEXUS™ Needle Disposal Container Sharps Container Accessory to Blood Collection Needles, Winged Sets and Catheters of Appropriate Size II 80 FMI new device 1224632
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. The BIO-PLEXUS™ Needle Disposal Container performs the same function as other legally marketed sharps containers, for example, the Vacutainer® Needle Disposal Container 367201. Specifically, this is to receive and accumulate contaminated blood collection needles and accessories in a puncture resistant container until final disposal can occur. 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.
§ 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).