Collector, Urine, Pediatric, For Indwelling Catheter
The Pediatric Urine Collector for Indwelling Catheter is a specialized collection bag or container designed to capture urine from pediatric patients connected to an indwelling catheter. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FFH, regulated under 21 CFR 876.5250, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FFH
- Device Class
- FDA class 2
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K905016 | PEDIATRIC AND INFANT CATH KITS | Dec 20, 1990 | Unknown | Davol, Inc. |
| K896581 | PEDIATRIC DRAIN BAG | Jan 31, 1990 | Substantially Equivalent | Laytech Medical Co. |
| K871789 | INTECARE PEDIATRIC URINE COLLECTOR | Aug 10, 1987 | Substantially Equivalent | Mercury Enterprises, Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.