Written and maintained by CASRAI Editorial Board
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General product information for supply, procurement and teaching staff. It is not medical advice and does not describe how any device is used on a patient; the manufacturer’s instructions for use (IFU) and the treating clinicians govern clinical use.
A lumbar drain kit is a packaged set of sterile, single-use components intended to drain cerebrospinal fluid (CSF) from the lumbar spine. In FDA terms it falls under 21 CFR 882.5550, the central nervous system fluid shunt and components regulation, which is Class II. Contents differ by manufacturer, so the checklist below pairs one real, FDA-database kit listing with the generic kit definition used in the global device nomenclature.
Purpose and setting
Readers who search for a lumbar drain kit or a lumbar drain system are usually supply-chain, biomedical or nursing-education staff who need to recognise what is, and is not, inside the package, and which regulatory category it belongs to. After reading, you should be able to compare a kit’s contents list against a checklist, read the key flags on its FDA database record, and know which regulation covers it.
The GMDN term recorded in FDA’s AccessGUDID for this product family, “Lumbar cerebrospinal fluid drainage catheterization kit”, defines it as a collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain CSF as a means of reducing CSF volume and intracranial pressure. It adds that the kit includes a spinal infusion or drainage catheter, devices for catheter insertion (for example a Tuohy needle, suture and guidewire) and devices for CSF collection (for example a drip chamber, drainage bag, tubing set and filter), and that it is a single-use device.
Lumbar drain kit contents checklist
The table below groups components by category. Kit listings vary: the “Example listing” column reflects one specific FDA-registered kit (Lumbar Catheter Accessory Kit, catalogue number 910121, checked in AccessGUDID on 2026-10-31), while “Generic definition” reflects the GMDN definition defined above. A dash means that source does not list the item. Always check the actual product’s labelling rather than assuming either column.
| Category | Item | Example listing (910121) | Generic definition | Notes |
|---|---|---|---|---|
| Access | Tuohy needle with obturator | 1 x 14-gauge thin-wall Tuohy needle with obturator | Listed as an example of an insertion device | Gauge is stated by the manufacturer for each kit. |
| Access | Guidewire | Guidewire in a dispenser | Listed as an example of an insertion device | Packaged in a dispenser in the example kit. |
| Drainage catheter | Radiopaque lumbar catheter | 80 cm, 5 Fr (1.6 mm outer diameter, 0.8 mm inner diameter), radiopaque, length marks every 2 cm | Spinal infusion/drainage catheter | Length, diameter and marking interval are product-specific. |
| Connection and securement | Luer-lock connector | 1 x Luer-lock connector | – | Connector supplied in the example kit. |
| Connection and securement | Butterfly suture clamp | 1 x butterfly suture clamp | Suture is listed as an example | Securement hardware differs between kits. |
| Collection circuit | Drip chamber, drainage bag, tubing set, filter | – | Listed as examples of CSF collection devices | The example accessory kit does not include these; a complete “system” may add them, packaged separately or together depending on the product. |
Kit versus system
The two phrasings describe the same family. The nomenclature definition places the catheter, insertion devices and collection devices inside one kit term, while the example listing above is an accessory kit covering the access, catheter and connection items only. When a purchasing or training document says “lumbar drain system”, read the product’s contents list to see whether the collection circuit is included.
What varies by facility type
Which items a facility stocks together typically depends on where drains are placed and managed, for example operating rooms, neurosurgical or anaesthesia services, and intensive care units. These are typical arrangements, not a regulatory requirement, and neither the regulation nor the database record prescribes a facility-specific list. The practical point for supply staff is that the kit’s own contents list, not the department, defines what is in the package, and that separate accessory kits and complete kits can both carry the same regulatory classification.
Storage, expiry and restocking
The example listing’s FDA record flags the product as supplied sterile, single use, prescription only, labelled with lot or batch number, manufacturing date and expiration date, and labelled as not made with natural rubber latex. The record lists no special storage or handling conditions. For any other kit, storage conditions, shelf life and handling are set by its own labelling and IFU.
- Check the expiration date and lot number on each kit; the example record shows that both are labelled on the product.
- Treat every kit as single use, as the nomenclature definition and the example record both state.
- Check the product’s current distribution status in the database before reordering. The example kit’s record shows “Not in Commercial Distribution” since 2021-12-31, so a listing can remain visible after a product has left the market.
Standards and rules that apply
21 CFR 882.5550 (checked on eCFR, 2026-10-31) identifies a central nervous system fluid shunt as a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle, for the purpose of relieving elevated intracranial pressure or fluid volume (for example due to hydrocephalus). It states that components include catheters, valved catheters, valves, connectors and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt. Its classification is Class II (performance standards). The example kit’s record carries FDA product code JXG, “Shunt, central nervous system and components”. The regulation does not itself list kit contents; those come from the manufacturer’s labelling. For background on how device classes arose, see the Medical Device Amendments of 1976.
Related CASRAI device guides cover neighbouring products: the external ventricular drain and the intracranial pressure monitor. For other catheter categories see central venous catheters and Foley catheters. General drainage catheter product categories are also listed under drainage catheters.
FAQ
What is the difference between a lumbar drain kit and a lumbar drain system?
Sources use the terms loosely. The GMDN kit definition includes both insertion devices and a CSF collection set (drip chamber, drainage bag, tubing, filter), while the example accessory kit lists only access, catheter and connection items. Check the contents list of the specific product.
Is a lumbar drain kit a Class II device?
Components of a central nervous system fluid shunt, including catheters and connectors, are classified Class II under 21 CFR 882.5550. The example kit’s record carries product code JXG under that regulation.
Is a lumbar drain kit single use?
Yes. The GMDN definition says the kit is a single-use device, and the example record flags it as single use and sterile.
What standard sizes do the catheters come in?
No size is universal. The example kit lists an 80 cm, 5 Fr catheter with 2 cm length marks and a 14-gauge Tuohy needle. Other products have their own dimensions.
Sources
- eCFR, 21 CFR 882.5550, Central nervous system fluid shunt and components: https://www.ecfr.gov/current/title-21/section-882.5550 (date checked: 2026-10-31).
- FDA AccessGUDID, Lumbar Catheter Accessory Kit, catalogue 910121, device identifier 10381780034124, including the GMDN term “Lumbar cerebrospinal fluid drainage catheterization kit”: https://accessgudid.nlm.nih.gov/devices/10381780034124 (date checked: 2026-10-31).
