Urinal
The Urinal is a portable receptacle used to collect urine from patients who are immobile or bed-bound, enabling voiding without requiring the patient to use a bathroom. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FNP, regulated under 21 CFR 880.6730 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FNP
- Device Class
- FDA class 1
- Regulation Number
- 880.6730
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K771738 | MALE URINAL | Sep 28, 1977 | Substantially Equivalent | Bemis Health Care |
FEI Numbers
This FDA classification entry is associated with 102 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 102 registration numbers. Click on an entry to view related FDA registrations.