BIO-PLEXUS NEEDLE DISPOSAL CONTAINER

K960933 · Bio-Plexus, Inc. · FMI · Aug 28, 1996 · General Hospital

Device Facts

• Record ID: K960933
• Device Name: BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
• Applicant: Bio-Plexus, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Aug 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The BIO-PLEXUS™ Needle Disposal Container 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.

Device Story

Single-use, one-quart, puncture-resistant sharps container; bucket-like base with affixed cover; three openings and two hinged lids; used by healthcare workers in clinical and home settings to receive and accumulate contaminated needles and accessories until final disposal; provides safe containment of sharps to prevent injury.

Clinical Evidence

bench testing only

Technological Characteristics

Polypropylene plastic injection molded bucket and cover; puncture-resistant; one-quart capacity; three openings with two hinged lids.

Indications for Use

Indicated for healthcare workers in healthcare facilities and home settings for the disposal of contaminated blood collection needles and accessories.

Regulatory Classification

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.

Predicate Devices

• Vacutainer® Needle Disposal Container 367201

Submission Summary (Full Text)

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AUG 28 1996
510 (k) SUMMARY
K960933

Bio-Plexus, Inc.
384 Merrow Road
Tolland, CT 06084

CONTACT: Carl R. Sahi (President)
Prepared: March 6, 1996
Revised: July 9, 1996

| Proprietary Name: | BIO-PLEXUS™ Needle Disposal Container |
| --- | --- |
| Generic Name: | Sharps Container |
| Classification Name: | Accessory to Blood Collection Needles, Winged
Sets and Catheters of Appropriate Size |
| Class: | II |
| Panel Code: | 80 |
| Product Code: | FMI |
| Reason for submission: | new device |
| Bio-Plexus Inc. Registration Number: | 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 polypropylene. 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.