Written and maintained by CASRAI Editorial Board
Published · Last updated
This page describes products and general use; it is not medical advice.
On this page
A closed IV catheter system is a peripheral intravenous catheter that arrives with its extension tubing already attached and is designed to keep blood inside the device while the catheter is placed. It is also called a closed system IV catheter or an integrated IV catheter. This page explains what the parts are, how the single-port and dual-port versions differ, and what the sizes and colour codes mean, using the FDA 510(k) summary for one cleared product, the BD Nexiva Closed IV Catheter System, as the worked example.
What is a closed IV catheter system?
A closed IV catheter system is an over-the-needle peripheral IV catheter with an integrated extension set, built so that blood stays contained during insertion. The FDA summary for the Nexiva product describes it as a “closed peripheral intravascular catheter system designed with an integrated extension set incorporating a single port or Y (dual)-port injection site.” “Closed system” and “integrated” therefore describe the same design idea from two angles: blood containment, and tubing that is part of the device rather than attached later.
In US regulation it is an intravascular catheter. 21 CFR 880.5200 defines that device as a slender tube with any necessary connecting fittings, inserted into the vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids, and classifies it as Class II. FDA lists the Nexiva closed-system clearances under product code FOZ (Intravascular Catheter).
Labelled population: the FDA summary states the devices may be used for any patient population “with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.”
How is a closed IV catheter system built?
The FDA summary lists these parts for the Nexiva system: a radiopaque catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter (single or dual port), vent plug, and, on dual-port versions, a pre-attached needle-free connector.
- Septum: designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter.
- Passive needle protection: the needle tip is protected when the needle is removed, which the summary says reduces the risk of accidental needlestick injury.
- Vent plug: prevents blood leakage from the extension tubing during insertion.
- Flashback technology: the product uses BD Instaflash needle technology for immediate visualization of blood along the catheter, with continuous blood return visible in the extension tubing.
- Stabilization platform: a built-in platform, colour coded by gauge (for securement as a separate device, see catheter securement devices).
Materials named in the summary include a polyurethane catheter with barium sulfate (which makes it radiopaque), a stainless steel needle, a low-density polyethylene needle cover, and a polypropylene vent plug. Sterilization is by ethylene oxide.
Single port versus dual port
The two layouts differ in the indications FDA cleared, not only in hardware. In the 2025 clearance (K243403), the indications for the dual-port configurations were narrowed so that blood pressure monitoring is no longer listed for them.
| Type | Cleared uses (FDA summary) | Key difference |
|---|---|---|
| Single port | Sample blood, monitor blood pressure, or administer fluids | Blood pressure monitoring is in the indication |
| Dual port (Y port, with a pre-attached needle-free connector such as BD Q-Syte or BD MaxZero) | Sample blood or administer fluids | Blood pressure monitoring is not in the indication |
The summary lists five configurations: Single Port; Single Port with MaxZero; Dual Port with Q-Syte; Dual Port with Q-Syte and End Cap; and Dual Port with MaxZero. A needle-free connector or end cap is supplied in the unit package, though not with every configuration. For what a connector-side protective cap does, see disinfecting caps.
Gauge, colour and length
For this product the stabilization platform and Luer connector are colour coded by gauge. The summary lists catheter diameters of 18, 20, 22 and 24 GA and lengths of 0.56, 0.75, 1.00, 1.25 and 1.75 inches.
| Gauge | Outer diameter | Colour code | Power injector note |
|---|---|---|---|
| 24 GA | 0.7 mm | Yellow | Not in the 22-18 GA power-injector statement |
| 22 GA | 0.9 mm | Blue | Suitable up to 300 psi (2068 kPa) under the condition below |
| 20 GA | 1.1 mm | Pink | Suitable up to 300 psi (2068 kPa) under the condition below |
| 18 GA | 1.3 mm | Green | Suitable up to 300 psi (2068 kPa) under the condition below |
Condition stated in the summary: the 22-18 GA devices are suitable for power injectors set to a maximum of 300 psi “when access ports not suitable for use with power injectors are removed.” For a general explanation of gauge numbering, see what an IV catheter is.
Regulation, labelling and handling
- Device class: intravascular catheter, Class II, short-term use (under 30 days) under 21 CFR 880.5200.
- Labelling is product specific: the colours, sizes and indications above come from the Nexiva summary, so each product’s own labelling and manufacturer instructions for use are the reference for that product.
- Needlestick design: the needle tip is passively protected on removal, which the FDA summary says reduces the risk of accidental needlestick injury; facility sharps policies still apply.
- Supply: sterile, single-use devices sterilized by ethylene oxide.
For hospital-level infection prevention context, see the CLABSI prevention bundle and saline flush. This page does not give insertion or use steps.
Frequently asked questions
What is a closed system IV catheter?
It is a peripheral IV catheter with an integrated extension set, designed to keep blood contained within the device during insertion, per the FDA 510(k) summary K243403.
What is an integrated IV catheter?
The term describes a catheter whose extension tubing, clamp and port are built in as one unit rather than added afterwards. The FDA summary uses the words “integrated extension set.”
How is a closed IV catheter regulated in the US?
As an intravascular catheter under 21 CFR 880.5200, Class II, product code FOZ. openFDA lists a series of Nexiva closed IV catheter system clearances under FOZ, from K032843 (2004-02-27) to K243403 (2025-07-25).
What are single-port and dual-port versions?
Single-port versions list sampling blood, monitoring blood pressure or administering fluids; dual-port (Y-port) versions list sampling blood or administering fluids, per K243403.
What do the colours on the platform mean?
In the Nexiva summary the colour identifies the gauge: 24 GA yellow, 22 GA blue, 20 GA pink and 18 GA green.
Where can I see IV catheters in a supply catalogue?
General product listings are in the IV catheters category. For a kit that bundles supplies, see IV start kits.
Sources
- FDA 510(k) summary K243403, BD Nexiva Closed IV Catheter System, decision 2025-07-25: accessdata.fda.gov/cdrh_docs/pdf24/K243403.pdf. Checked 2026-10-30.
- 21 CFR 880.5200, Intravascular catheter: law.cornell.edu/cfr/text/21/880.5200. Checked 2026-10-30.
- openFDA 510(k) database, product code FOZ clearances for Nexiva: api.fda.gov/device/510k.json (device_name nexiva, product code FOZ). Checked 2026-10-30.
