BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233529 FDA 510(k)
- FDA Product Code
- FOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5200 FDA 510(k)
- Regulation Number
- 880.5200 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector is a closed intravenous catheter system designed for peripheral venous access. It integrates a diffusion barrier to reduce the risk of bacterial infiltration while maintaining fluid administration and monitoring capabilities, ensuring a secure and sterile connection between the catheter and infusion line.
This system is intended for single-use in hospital settings, including general wards, and is supplied sterile. The BD MaxZero Needle-free Connector eliminates the need for manual needle insertion, reducing the risk of contamination. Authorized under FDA 510(k) clearance (K233529) and MDR compliance, it adheres to regulatory standards for infusion therapy devices. The product is available in standard peripheral catheter sizes as specified in the device documentation.
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: Becton Dickinson – Wikipedia, BD (company) - Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233529 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton Dickinson Infusion Therapy Systems Inc.
- FDA Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
Sources (2)
- FDA 510(k) K233529 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026