Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice. Follow the instructions your own clinic or laboratory gives you.
Short answer
A urine hat, also called a urine collection hat or specimen hat, is a shallow container that sits under a toilet seat to catch urine so it can be measured or poured into a labeled container. In US regulation it falls under FDA product code NNI, a Class I specimen container under 21 CFR 864.3250.
Definition and scope
The term is informal. FDA does not classify a device called a "urine hat"; its device database files specimen hats under product code NNI, "Container, Specimen, Non-Sterile", regulation number 864.3250, in the Pathology specialty. 21 CFR 864.3250 defines the category as a device intended to contain biological specimens, body waste or body exudate during storage and transport so that the matter can be destroyed or used effectively for diagnostic examination. (Sources: FDA openFDA classification record and 21 CFR 864.3250, checked 2026-10-30; see Sources below.)
Two points about that classification:
- It is Class I (general controls) and exempt from premarket notification, subject to the limitations in 21 CFR 864.9.
- The regulation states that it does not apply to specimen containers intended as part of an over-the-counter test sample collection system for drugs of abuse testing. That is a statement about the regulation’s scope; it does not say how a hat may or may not be used in any testing program.
FDA’s AccessGUDID data shows how the product is listed. One record carries the description "SPECIMEN HAT BLACK GRADUATIONS", is marked single use, sits under product code NNI and is shown as in commercial distribution. A second record from a hospital-supplies distributor describes a "Top Hat Specimen Collector", also single use. These are examples of label descriptions, not recommendations.
How a urine hat is used in a 24-hour collection
The best-documented use is a 24-hour urine collection. Memorial Sloan Kettering Cancer Center’s patient-education sheet "24-Hour Urine Collection" says that a person who is male is given a handheld urinal and a person who is female is given a urine collection "hat", and that someone staying in hospital may be given a bedpan instead. That is one institution’s instruction, not a universal rule.
The same sheet gives these rules for the hat:
- The hat is placed under the toilet seat and urine is passed into it.
- Toilet paper does not go in the urinal, collection hat or bedpan; it goes in the toilet.
- After each void, the urine is poured from the hat into the labeled collection container.
- The hat and the labeled container travel with the person if they leave home or the hospital room.
The sheet also says the labeled container is kept cold. A different laboratory may specify different preservation or timing, so the ordering clinic’s instructions govern.
Hat, urinal, bedpan and catheter compared
The rows below summarize what each named source says.
| Collection route | What the source says | Source |
|---|---|---|
| Urine collection hat | Placed under the toilet seat; urine is poured into the labeled container after each void. | Memorial Sloan Kettering, 24-Hour Urine Collection |
| Handheld urinal | Given to male patients in the same protocol; a body waste receptacle for a bed patient under 21 CFR 880.6730. | MSK; FDA via urinal types |
| Bedpan | May be given to a person staying in hospital in the same protocol. | MSK; see bedpan guide |
| Catheter | "The use of catheters is the most accurate method for measuring UO [urine output] in patients." Bottle collection, commodes and pads are listed as other methods. | StatPearls, Normal and Abnormal Urine Output and Interpretation |
Where it matters for labs and clinics
Output measurement matters because, per StatPearls, urine output must be measured accurately to analyze changes in production through the day. A hat is a collection aid; it is not itself a measuring standard, and the chapter does not discuss hats.
For supply and records purposes, the classification gives staff a consistent way to find the product: product code NNI and 21 CFR 864.3250. The hat is a Class I, single-use-listed specimen container and should not be confused with a sterile specimen cup or a collection kit. For those, see specimen container, urine collection kit and urimeter.
Common misunderstandings
Is a urine hat a specimen cup?
No. In the MSK protocol the hat only catches the urine; the urine is then poured into the labeled container that holds the collection.
Does the FDA regulation cover it for drug testing?
21 CFR 864.3250 excludes specimen containers intended as part of an over-the-counter test sample collection system for drugs of abuse testing. The regulation does not give rules for using a hat in a testing program.
Is it the most accurate way to measure output?
StatPearls identifies catheters as the most accurate method; collection devices such as commodes and bottles are described as other options.
FAQ
What is a urine collection hat?
It is a shallow collection container placed under a toilet seat. In the MSK 24-hour collection sheet, a person who is female is given one and pours the urine into the labeled container after each void.
What is the FDA product code for a specimen hat?
Specimen hats are listed under NNI, "Container, Specimen, Non-Sterile", regulation 21 CFR 864.3250, Class I.
Is a urine hat the same as a urinal?
No. A urinal is a handheld receptacle for a bed patient under 21 CFR 880.6730; the hat sits under the toilet seat. See urinal types.
Can toilet paper go in the hat?
Not under the MSK instructions: toilet paper goes in the toilet and is flushed.
Sources
All sources checked 2026-10-30.
- FDA openFDA device classification, product code NNI: https://api.fda.gov/device/classification.json?search=product_code:NNI
- 21 CFR 864.3250, Specimen transport and storage container: https://www.law.cornell.edu/cfr/text/21/864.3250
- FDA AccessGUDID data via openFDA UDI: https://api.fda.gov/device/udi.json?search=device_description:%22specimen+hat%22
- Memorial Sloan Kettering Cancer Center, "24-Hour Urine Collection": https://www.mskcc.org/pdf/cancer-care/patient-education/24-hour-urine-collection
- StatPearls, "Normal and Abnormal Urine Output and Interpretation": https://www.ncbi.nlm.nih.gov/books/NBK606132/
