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510(k) Data Aggregation
K Number
K151249Device Name
PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON
Manufacturer
Date Cleared
2015-09-04
(115 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
PUREWAY COMPLIANCE, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PureWay® Sharps Collector container is a disposable infectious waste container in 1.2 gallon, 2 gallon and 3 gallon sizes, intended for use in a healthcare setting. The PureWay® Sharps Collector container will be ultimately destroyed through incineration.
There are three indications for use statements corresponding to three sizes of container. These are reproduced below:
Indications for Use Statement: 1.2 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75″ x 6″ x 7.27″ and weighs 7oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, sinqle use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Indications for Use Statement: 2 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75″ x 6″ x 11.15″ and weighs 11b 1oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Indications for Use Statement: 3 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75" x 15.73" and weighs 2 Ibs. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Device Description
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic and is available in 1.2 Gallon and 3 Gallon sizes. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal.
Each container is non-sterile, single use, disposable infectious waste container).
The containers are designed to contain and hold sharps such as anqio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture.
In summary, all PureWay® Sharps Collector containers are blow molded usinq High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure.
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