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510(k) Data Aggregation
K Number
K133031Device Name
SHARPSOLOGY 2
Manufacturer
INDUSTRIAL WATER SOLUTIONS, INC.
Date Cleared
2013-11-15
(50 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
INDUSTRIAL WATER SOLUTIONS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The container is intended for use in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.
Device Description
The Sharpsology 2 is a reusable plastic sharps disposal container. The container is a nonsterile device for nonsterile applications. The container is intended to be used in an appropriate wall mount unit, wall bracket or stand alone tray. It features a canteen style, vertical drop lid and a mailbox style, vertical drop lid for safe and easy disposal of sharps. Simply deposit syringes vertically into the opening of the lid, and they are deposited automatically into the container. Container is easily identified as full by looking at both the fill line on the container and biohazard label attached to container. When the canteen style lid is being used and the container is full, the supplied cap is attached to the lid by turning clockwise until it snaps into place for transport. When using the mailbox style lid and the container is full, pull the rotating portion of lid forward and snap lock the rotating portion into the two locking tabs located on the front of the lid. The Sharpsology 2 has a hole in one end of the lid and container that match, a plastic cable wire tie is inserted to look the lid to the container for transportation. Then just replace it with a clean sanitized unit, Using proper cleaning and sterilizing equipment, cleaning facility will empty and sanitize the unit and return it to the user facility to use for the next switch out. The durable high-density polypropylene specialty impact copolymer construction of the Sharpsology 2 makes it leak resistant, puncture resistant and stable. It meets or exceeds all OSHA recommendations for sharps containers, and because it is reusable, it is more environmentally friendly and less expensive than disposable alternatives. The projected life expectancy of the device is at least (5) five years. Other sharps containers using the same material for the same purpose have remained in use over (5) five years without showing failure. The container is intended to be used in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.
The Sharpsology 2 container is inserted into a wall mount unit available from Industrial Water Solutions, Inc. that is lockable and allows access to the opening of the lid of the Sharpsology 2 container for needle disposal. Healthcare personnel drop used sharps into the opening of the lid of the container, Sharps drop to the bottom of the container. When the container is full or up to the "Fill Line" of the container, the container is then taken out of the wall mount or bracket on the wall. The label on the container has very visible "Fill Line" imprinted on the outside. The container also has a very visible fill line, as well. A new container or one that has been sanitized for reuse is then put back into the wall mount or bracket for use. The container is then ready for transport to the cleaning facility for sanitation.
A label will be attached to the container specifying the intended use of the container. A sample of this label is attached at the end of this document. (See Attachment 1)
The Sharpsology 2 container is a reusable two gallon sharps container used for the collection of sharps at the healthcare facility. The container is housed in a wall mount or bracket attached to the wall. Healthcare personnel simply drop used sharps into the vertical drop opening on top of the lid and release. The used sharps deposited into the container and drop to the bottom of the container. The container is used until it is deemed to be full by visually inspecting to see if the sharps level is up to the "Fill Line". Once the container is deemed to be full, it is then removed from the wall mount or bracket and gotten ready for transport. A new container or a used, sanitized container is then placed in the wall mount or bracket for use, The Sharpsology 2 container has no handles, but is easily picked up by placing hands on either side of the container and lifting. The average weight of the container plus sharps inside a full container will average five and seven pounds. The used or full containers are then transported to the cleaning and sanitizing facility for sanitation, inspection, packaging, and made ready for reuse. The container is lockable. Each container has a bayonet style lid closure that horizontally slides into place and is removed mechanically for emptying and cleaning. The lid features a wire tie to further help hold the lid in place.
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K Number
K083511Device Name
ENVIRO SHARP SOLUTIONS 3
Manufacturer
INDUSTRIAL WATER SOLUTIONS, INC
Date Cleared
2009-03-03
(97 days)
Product Code
MMK
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
INDUSTRIAL WATER SOLUTIONS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles are generated. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.
Device Description
The Enviro Sharp Solutions 3 is a reusable plastic sharps disposal container. It features a mail drop, torturous path tumbler lid for safe and easy disposal of sharps. Simply deposit syringes horizontally into the opening of the lid, and they are deposited automatically into the container. When the container is full, the tumbler will indicate that it is time to replace the unit. Just insert the locking tabs to secure the container in a closed position and replace it with a clean sanitized unit. Using our proprietary equipment, Sci-Med Waste employees will empty and sanitize the unit and return it to the facility to use for the next switch out. The durable high-density polyethylene construction of the Enviro Sharp Solutions 3 makes it leakproof, puncture resistant and stable. It meets or exceeds all OSHA recommendations for sharps containers, and because it is reusable, it is more environmentally friendly and less expensive than disposable alternatives.
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