FAQ · Bag, Urine Collection, Leg, For External Use, Sterile
Gastroenterology, Urology · 21 CFR 876.5250 · Class 1
Overview
| Product Code | FAQ |
|---|---|
| Device Name | Bag, Urine Collection, Leg, For External Use, Sterile |
| Regulation | 21 CFR 876.5250 |
| Device Class | Class 1 |
| 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962604 | PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING | Convatec, A Division of E.R. Squibb & Sons | Jul 18, 1996 | SESE |
| K960217 | CPR URINE BAG | Custom Pack Reliability | Mar 28, 1996 | SESE |
| K955609 | CONVEEN URINE BAG - STERILE | Coloplast Corp. | Dec 29, 1995 | SESE |
| K953767 | PROSYS BEDSIDE DRAINAGE BAG | Convatec, A Division of E.R. Squibb & Sons | Dec 20, 1995 | SESE |
| K953783 | CONVEEN LEG BAG STRAP | Coloplast Corp. | Sep 13, 1995 | SESE |
| K951945 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | May 25, 1995 | SESE |
| K945204 | URINE COLLECTOR & ACCESSORIES | Nelmed Corp. | Nov 2, 1994 | SESE |
| K934052 | ALPINE REUSABLE LEG BAGS | Sierra Laboratories, Inc. | Jan 7, 1994 | SESE |
| K931727 | URINARY DRAINAGE BAG CADDY | Neotech Products, Inc. | Jul 23, 1993 | SESE |
| K926035 | BARD LEG BAG HOLDER | C.R. Bard, Inc. | Dec 17, 1992 | SESE |
| K924406 | CONVEEN(R) LEG BAG(500 ML) | Coloplast A/S | Oct 30, 1992 | SESE |
| K903611 | ILC LEG BAG HOLDER | Inman Liebelt Corp. | Oct 26, 1990 | SESE |
| K901219 | EXTERNAL LEG BAG | Orion Life Systems, Inc. | Jun 27, 1990 | SESE |
| K896129 | URINARY LEG BAG | Cypress Medical Products, Ltd. | Apr 16, 1990 | SESE |
| K896728 | 4 SURE URINARY LEG BAG | The Boston & Pacific Co., Inc. | Feb 20, 1990 | SESE |
| K780190 | CATHETER STRAP & RUINARY BAY HOLDER | Baka Manufacturing Co., Inc. | Feb 21, 1978 | SESE |
| K772402 | QUADRIPLEGIC URINARY DRAINAGE VALVE | Fred Sammons, Inc. | Jan 26, 1978 | SESE |
| K780032 | URINARY LEG BAG | C.R. Bard, Inc. | Jan 17, 1978 | SESE |
Top Applicants
- Convatec, A Division of E.R. Squibb & Sons — 3 clearances
- Coloplast Corp. — 2 clearances
- C.R. Bard, Inc. — 2 clearances
- The Boston & Pacific Co., Inc. — 1 clearance
- Sierra Laboratories, Inc. — 1 clearance
