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Nexus Iv Tubing Set With Luer-Accessbile One-Way Check Valve - Iv Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130879

by Nexus Medical, LLC

Identifiers

510(k) Number
K130879 FDA 510(k)
FDA Product Code
FPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Intravascular Administration Set (product code FPA) designed to facilitate the administration of intravenous fluids and medications. The integrated Luer-accessible one-way check valve prevents backflow, reducing the risk of contamination and needle-stick injuries while maintaining fluid integrity during infusion.

The Nexus IV Tubing Set is intended for single-use in hospital or clinical settings and has received FDA 510(k) clearance under the General Hospital Advisory Committee. Supplied sterile, it is classified as a Class II medical device under Special Controls and must be handled according to standard aseptic protocols. No additional regulatory approvals beyond the stated clearance are implied.

Frequently asked questions

What is the primary purpose of the one-way check valve in the Nexus IV Tubing Set, and how does it improve patient safety during IV administration?

The one-way check valve in the Nexus IV Tubing Set prevents backflow of fluids, which significantly reduces the risk of contamination and needle-stick injuries. This feature ensures that infused medications or fluids remain contained within the tubing, maintaining their integrity and minimizing exposure to pathogens or accidental contamination during use.

Is the Nexus IV Tubing Set intended for reuse in clinical settings, and if not, what are the implications for handling and disposal?

No, the Nexus IV Tubing Set is explicitly designed for single-use only in hospital or clinical environments. Since it is supplied sterile, reuse could compromise sterility and patient safety, leading to potential infections or infusion errors. Proper disposal after a single use is required to adhere to aseptic protocols and regulatory guidelines.

What storage conditions should be followed for the Nexus IV Tubing Set to ensure its sterility and functionality before use?

The device is supplied sterile, so it must be stored in its original, unopened packaging to maintain sterility. It should be kept in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Avoid exposing the packaging to moisture or contaminants, as this could compromise the sterility barrier before use.

How does the Nexus IV Tubing Set differ from standard IV tubing in terms of safety features, and why might a clinician choose this product?

Unlike standard IV tubing, the Nexus IV Tubing Set includes a Luer-accessible one-way check valve, which actively prevents backflow of fluids—reducing contamination risks and needle-stick hazards. Clinicians may prefer this product for procedures requiring frequent access (e.g., medication administration or blood sampling) where maintaining fluid integrity is critical, as it minimizes exposure to potential pathogens while allowing controlled access.

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: Nexus Iv Tubing Set With Luer-accessbile One-way Check Valve - Iv Plus, Mods - Nexus Mods, K130879 FDA 510(k) - NEXUS IV TUBING SET WITH LUER-ACCESSBIL..., NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nexus Medical, LLC

Sources (1)

  • FDA 510(k) K130879 24 fields · synced Oct 6, 2026