Nexus Intravenous Tubing Sets (NIVTS)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K041861 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)
Nexus Intravenous Tubing Sets are medical devices designed for the administration of intravenous fluids and medications. The system utilizes a needle-free interface to connect to the patient's vascular system, which is intended to reduce the risk of needle-stick injuries to healthcare providers.
These tubing sets are supplied by Nexus Medical, LLC and have received FDA 510(k) clearance under K041861. The device is intended for use in a general hospital setting to facilitate the delivery of fluids or medication.
Frequently asked questions
What is the primary purpose of the Nexus Intravenous Tubing Sets?
These tubing sets are designed for use in general hospital settings to facilitate the administration of intravenous fluids and medications to patients.
How does the device help protect healthcare providers?
The system incorporates a needle-free interface for connecting to the patient's vascular system, which is intended to reduce the risk of accidental needle-stick injuries during clinical procedures.
What is the regulatory status of the Nexus Intravenous Tubing Sets?
The Nexus Intravenous Tubing Sets have received FDA 510(k) clearance under K041861, confirming that the device has been found substantially equivalent to legally marketed predicate devices.
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 INTRAVENOUS TUBING SETS (NIVTS) - Innolitics, Nexus Medical Catalog, K041861 FDA 510(k) - NEXUS INTRAVENOUS TUBING SETS (NIVTS), Nexus Iv Tubing Set With Luer-accessbile One-way Check Valve - Iv Plus
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041861 | Class II | Active |
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Manufacturer
- Manufacturer
- Nexus Medical, LLC
Sources (1)
- FDA 510(k) K041861 24 fields · synced Oct 6, 2026