PureWay®

FDA UDI

Class II (US FDA UDI)

by Pureway Compliance, Inc.

Identity

Trade Name: PureWay® FDA UDI
Generic Name: Sharps container FDA UDI
Device Name: 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. 1.2 gallon four pack sharps disposal ship back system (Includes four 1.2 gallon sharps container, box, bag, zip tie) FDA UDI
Model / Reference: 8 FDA UDI
Description: 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. 1.2 gallon four pack sharps disposal ship back system (Includes four 1.2 gallon sharps container, box, bag, zip tie) FDA UDI

Identifiers

Catalog Number: 40041 FDA UDI
Primary DI / UDI-DI: 10853022008052 FDA UDI
510(k) Number: K151249 FDA UDI
FDA Product Code: MMK FDA UDI
GMDN Term: Sharps container FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1.2 Gallon FDA UDI

Category: Sharps container

PureWay® by Pureway Compliance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sharps container.

SharpSafety — Cardinalhealth · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class II
SharpSafety — Cardinalhealth · Class II
SharpsTank — REHRIG PACIFIC COMPANY · Class II
BD Sharps Collector — BECTON DICKINSON AND COMPANY · Class II
Stericycle Reusable Sharps Container — Stericycle, Inc. · Class II
Daniels — DANIELS CORPORATION INTERNATIONAL PTY LTD · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Pureway Compliance, Inc.

Sources (1)

FDA UDI 5a2c1476-90bb-4042-a22f-0d535a4a8a73 36 fields · synced May 30, 2026