External Ventricular Drain (EVD): Kit Contents and FDA Class

This page describes products and general use; it is not medical advice.

An external ventricular drain (EVD) is a sterile, single-use drainage set that connects a catheter placed in the brain’s fluid-filled ventricles to tubing and a collection system outside the body. This page is for supply buyers, materials-management staff and students who need to know what an EVD kit contains, how regulators classify the parts, and which kit specifications are model-specific rather than universal.

What an external ventricular drain is

The Global Medical Device Nomenclature (GMDN) term 61798, “Ventricular cerebrospinal fluid drainage catheterization kit”, describes it as “a collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF)”. Searchers also call it an EVD drain or EVD kit; all three phrases point to the same product class. The example kit record below is a prescription (Rx) device, so it is used under clinician direction. Sizes, volumes and accessory lists differ from one manufacturer’s kit to the next.

What is in an EVD kit

The GMDN definition says a kit includes a catheter, insertion devices such as a stylet, and CSF collection parts: a drip chamber, a drainage bag and a tubing set. The FDA’s AccessGUDID record for one labeled kit (Integra External Drainage Set, catalog 910112A, checked 2026-10-30) shows how those parts are described in practice.

Component	How the sources describe it
Ventricular catheter	A device used to gain access to the cavities of the brain (21 CFR 882.4100)
Insertion device (stylet or introducer)	Listed in the GMDN kit definition; the example record lists introducers
Extension tubing	The example set uses an extension tubing line with a T fitting and a four-way stopcock
Drip chamber or cylinder	Listed in the GMDN definition; the example set has a 75 ml cylinder
Drainage bag	Listed in the GMDN definition; the example bag has a hydrophobic filter

Drain versus shunt

An EVD diverts fluid to an external bag. FDA’s regulation 21 CFR 882.5560, “Cerebrospinal fluid shunt system”, describes a prescription device “used to monitor and divert fluid from the brain”. The regulation title names the shunt system as a category, and the example kit is filed under FDA product code JXG, “Shunt, central nervous system and components”. So the regulatory vocabulary says “shunt” even where the product is a temporary external drain; read a record’s description before assuming a “shunt” label means an implanted device.

Specifications on a labeled kit (one worked example)

The values below come from one AccessGUDID record (Integra External Drainage Set 910112A, checked 2026-10-30). That model is no longer in commercial distribution (distribution ended 2021-12-31), so treat it as an example of how a kit is labeled, not as a standard size.

Item	Value on this record
Drainage bag	500 ml
Cylinder	75 ml
Pressure scale	350 mm H2O drainage pressure scale
Ventricular catheter	35 cm long, 2.7 mm outer diameter, 1.4 mm inner diameter (F8)
Introducers	22 cm and 37 cm
Packaging and labeling	Sterile, single-use, prescription; storage not to exceed 60 C

Regulatory classification

Item	Regulation	Class
Ventricular catheter	21 CFR 882.4100	Class II (performance standards)
Cerebrospinal fluid shunt system	21 CFR 882.5560	Class II (special controls)

For the framework behind these classes, see the CASRAI glossary entries on the Medical Device Amendments of 1976 and medical device reporting.

Safe use and handling basics

The example kit is labeled sterile and single-use, and its record lists a storage ceiling of 60 C. Placement, management and removal of an EVD are clinical procedures governed by the manufacturer’s instructions for use and hospital protocol; they are outside the scope of this page.

Common mistakes

• Treating one kit’s sizes as universal. Bag volume, cylinder volume and catheter length are model-specific; read the labeling of the exact catalog number.
• Treating the catheter and the kit as one regulatory item. The catheter appears under 21 CFR 882.4100, while the example complete set is filed under product code JXG.
• Assuming “shunt” means implanted. The regulatory category name is broad; check the device description.

For related device explainers, see neurosurgical instruments, central venous catheters, Foley catheters and sterile drapes. Supplies in the wider drainage catheter family are listed under drainage catheters.

FAQ

What is an external ventricular drain?

It is a sterile kit for short-term access to the brain ventricles to drain cerebrospinal fluid into an external collection system (GMDN 61798).

What does an EVD kit contain?

Per GMDN, a catheter, insertion devices such as a stylet, and CSF collection parts: a drip chamber, drainage bag and tubing set. Exact contents vary by model.

Is an EVD drain the same as a shunt?

FDA files both under the “shunt” regulatory vocabulary (21 CFR 882.5560, product code JXG), but an EVD drains to an external bag. Check each product’s description.

What FDA class is an EVD?

The ventricular catheter (21 CFR 882.4100) and the cerebrospinal fluid shunt system (21 CFR 882.5560) are both Class II.

Sources

• FDA AccessGUDID record, Integra External Drainage Set 910112A (GMDN 61798; product code JXG), https://accessgudid.nlm.nih.gov/devices/10381780035527, checked 2026-10-30.
• 21 CFR 882.5560, Cerebrospinal fluid shunt system, https://www.law.cornell.edu/cfr/text/21/882.5560, checked 2026-10-30.
• 21 CFR 882.4100, Ventricular catheter, https://www.law.cornell.edu/cfr/text/21/882.4100, checked 2026-10-30.