FFH · Collector, Urine, Pediatric, For Indwelling Catheter
Gastroenterology, Urology · 21 CFR 876.5250 · Class 2
Overview
| Product Code | FFH |
|---|---|
| Device Name | Collector, Urine, Pediatric, For Indwelling Catheter |
| Regulation | 21 CFR 876.5250 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and (2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
Classification Rationale
(1) Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Special Controls
*Classification* —(1)*Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter.* The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) *Class I (general controls).* For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K905016 | PEDIATRIC AND INFANT CATH KITS | Davol, Inc. | Dec 20, 1990 | SESD |
| K896581 | PEDIATRIC DRAIN BAG | Laytech Medical Co. | Jan 31, 1990 | SESE |
| K871789 | INTECARE PEDIATRIC URINE COLLECTOR | Mercury Enterprises, Inc. | Aug 10, 1987 | SESE |
Top Applicants
- Davol, Inc. — 1 clearance
- Laytech Medical Co. — 1 clearance
- Mercury Enterprises, Inc. — 1 clearance
