Red2Green Reusable Sharps Container
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153363 FDA 510(k)
- FDA Product Code
- MMK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Red2Green Reusable Sharps Container is a reusable medical waste container designed for the collection of regulated sharps, such as needles and syringes. Classified as a sharps container, it is intended to safely contain and segregate hazardous sharps waste to prevent needlestick injuries and ensure proper disposal.
This device is supplied as a reusable container, intended for use in general hospital settings. It is not sterile and requires cleaning and maintenance between uses. The container is available in multiple sizes, including a 10-gallon variant, and is regulated under FDA 510(k) clearance (K153363) as a Class II device. Compliance with specific opening, washing, and disposal protocols is required to maintain its functionality and safety.
Frequently asked questions
What types of medical waste can the Red2Green Reusable Sharps Container safely hold, and is it suitable for general hospital use?
The Red2Green Reusable Sharps Container is specifically designed to safely collect and segregate regulated sharps waste, such as needles and syringes, to prevent needlestick injuries. It is intended for use in general hospital settings, as indicated by its FDA 510(k) clearance under the product code MMK and advisory committee classification for general hospitals. It is not intended for non-sharp medical waste.
Is the Red2Green Reusable Sharps Container sterile, and what maintenance does it require between uses?
The Red2Green Reusable Sharps Container is not sterile and must be cleaned and maintained between uses. Since it is reusable, proper cleaning and disinfection protocols are required to ensure safety and functionality, as outlined in the manufacturer’s instructions.
What sizes are available for the Red2Green Reusable Sharps Container, and how do I determine the right fit for my facility?
The Red2Green Reusable Sharps Container is available in multiple sizes, including at least a 10-gallon variant, though other sizes may be listed under the provided FEI numbers. The appropriate size depends on your facility’s sharps waste volume—consult the manufacturer’s guidelines or contact Triumvirate Environmental for recommendations based on your specific workflow.
How is the Red2Green Reusable Sharps Container regulated, and what does its FDA 510(k) clearance mean for my facility?
The Red2Green Reusable Sharps Container holds an FDA 510(k) clearance (K153363) as a Class II device, meaning it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with U.S. safety and performance standards for sharps containers in general hospital settings, but it does not imply approval for specific clinical uses—only that it meets regulatory requirements for its intended purpose.
What protocols must my facility follow to ensure proper use, cleaning, and disposal of the Red2Green Reusable Sharps Container?
The Red2Green Reusable Sharps Container requires adherence to specific opening, washing, and disposal protocols to maintain safety and functionality. These protocols are detailed in the manufacturer’s instructions and may include proper cleaning procedures, inspection for damage, and compliance with OSHA or local regulations for sharps waste handling. Always follow the provided guidelines to avoid contamination or injury risks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Triumvirate Environmental Red2Green Reusable Sharps Container, AccessGUDID - DEVICE: Triumvirate Environmental Red2Green Reusable ..., PDF Everything You Want to Know About Our Container Options, Triumvirate Environmental Red2Green Reusable Sharps Container
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153363 | Class II | Active |
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Manufacturer
- Manufacturer
- Triumvirate Environmental, Inc.
Sources (1)
- FDA 510(k) K153363 24 fields · synced Sep 19, 2026