Collector, Urine, Powered, Non Indwelling Catheter
The Collector, Urine, Powered, Non Indwelling Catheter (product code NZU) is a powered, non-invasive, non-sterile urine collection device intended for patients who are unable to void on their own or have no voluntary control of voiding, such as those confined to a bed or wheelchair. It is classified as FDA Class 1, GMP-exempt, and regulated under 21 CFR 876.5250 within the Gastroenterology and Urology specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NZU
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
Definition
For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.
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 |
|---|---|---|---|---|
| K062061 | URASSIST | Oct 05, 2006 | Substantially Equivalent | Preferred Medical Devices, Inc. |
FEI Numbers
This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.