PureWay® 40022

GUDID 10853022008069

The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. 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. The containers are designed to contain and hold sharps such as angio-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 using 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. 2 gallon twin pack sharps disposal ship back system (Includes two 2 gallon sharps container, box, bag, zip tie).

PUREWAY COMPLIANCE

Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container Sharps container

• Primary Device ID: 10853022008069
• NIH Device Record Key: 4c1804f2-dec5-45ba-865d-3b3632ab95a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureWay®
• Version Model Number: 9
• Catalog Number: 40022
• Company DUNS: 064845056
• Company Name: PUREWAY COMPLIANCE
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon
• Total Volume: 2 Gallon

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853022008062 [Unit of Use]
GS1	10853022008069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151249

FDA Product Code

• MMK: Container, Sharps

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-08-18
• Device Publish Date: 2018-01-15

On-Brand Devices [PureWay®]

• 10853022008090: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.
• 10853022008083: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.
• 10853022008076: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.
• 10853022008069: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.
• 10853022008052: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.
• 10853022008045: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.
• 10853022008038: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.
• 10853022008021: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.
• 10853022008014: The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic.