Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
A urinal is a hand-held container that collects urine from a patient who is in bed or cannot easily reach a toilet. This page sets out how FDA classifies it, the variants that appear on FDA-listed device labels, and the capacities those labels state.
What is a urinal?
In US regulation a urinal is a type of “body waste receptacle”: under 21 CFR 880.6730, “a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.” FDA’s device classification database lists the product as “Urinal” (product code FNP) in the General Hospital specialty. It is a Class I device (general controls) and is exempt from premarket notification, subject to the limitations in 21 CFR 880.9.
Who uses it: bed patients, per the regulation’s wording, and the nurses, aides and caregivers who help them. Because the device is “not attached to the body”, it is a different product from a catheter; see male external catheter types, which covers body-worn “drip” collection devices.
Types of urinals
FDA’s Global UDI Database (AccessGUDID) holds 65 records under product code FNP. The table groups how those records describe the product. The entries are examples of label descriptions, not endorsements.
| Type | How the FDA-listed label describes it | Key difference |
|---|---|---|
| Male urinal, reusable | “Urinal, Male” and “Male Urinal With Cover” records, flagged not single-use | Shaped for male use; intended to be cleaned and used again |
| Female urinal, reusable | “Urinal, Female” and “Urinal Female Plastic” records, flagged not single-use | Shaped for female use |
| Single-use male urinal | “Urinal, Male, 32 oz, Non-Sterile” and “Male Urinal, 1000 mL” records, flagged single-use | Supplied as single-use with a stated volume |
| Urinal with cover | “Urinal w/TransCvr” (transparent cover) records | A lid or cover is part of the product |
| Urinal with comfort ring | “Urinal w/Comfort Ring Att” record | A comfort ring attachment is included |
| Unisex urinal with lid | “Universal Urinal” record with an “attached snap-on lid” | Described as a universal urinal with a lid that attaches to the container |
| Disposable urinal bag | “Disposable Urinal Bags” records, including resealable and wider-adaptor variants, flagged single-use | A bag rather than a rigid container |
Latex labelling differs from record to record, so the type of urinal says nothing about latex content. Check the label of the specific product.
Sizes stated on FDA-listed labels
| Stated capacity | Label description | Source record |
|---|---|---|
| 32 oz | “Urinal, Male, 32 oz, Non-Sterile” (single-use) | AccessGUDID, 2022 record |
| 1000 mL | “Male Urinal, 1000 mL” (single-use) | AccessGUDID, 2020 record |
| 1 qt / 1000 cc | “Urinal- Male, 1000c/1qt., Transparent with Graduated Markings” (single-use) | AccessGUDID, 2021 record |
These are the capacities stated on the three single-use male urinal labels above; 32 oz is about 0.95 L, so the three are close to a litre.
Urinal vs bedpan vs commode
All three collect body waste from a patient who cannot use a standard toilet. A urinal is the device for urine alone. The other two are covered on their own pages: what is a bedpan (which answers whether a bedpan and a urinal are the same) and what is a bedside commode. For clinics stocking these items, the urology clinic supply checklist shows where they sit among other supplies, and urology and incontinence supplies lists related product categories.
FAQ
What is a urinal?
A urinal is a medical container, not attached to the body, that collects urine from a bed patient. FDA classes it as a Class I “body waste receptacle” (21 CFR 880.6730, product code FNP).
What types of urinal are there?
FDA-listed labels describe male, female and unisex urinals, reusable and single-use versions, models with a cover or comfort ring, and disposable urinal bags.
Is a urinal a regulated medical device?
Yes. It is Class I (general controls) and exempt from premarket notification, subject to the limitations in 21 CFR 880.9.
Sources
- 21 CFR 880.6730, Body waste receptacle, Legal Information Institute, checked 2026-10-30: law.cornell.edu/cfr/text/21/880.6730
- FDA device classification database, product code FNP (openFDA), checked 2026-10-30: api.fda.gov device classification
- FDA Global UDI Database (AccessGUDID / openFDA UDI), product code FNP, checked 2026-10-30: api.fda.gov device UDI
