EYZ · System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Gastroenterology, Urology · 21 CFR 876.5250 · Class 1
Overview
| Product Code | EYZ |
|---|---|
| Device Name | System, Urine Drainage, Closed, For Nonindwelling Catheter, 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 (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964219 | ZIP CONDOM CATHETER | Goulter Medical, Inc. | Aug 11, 1997 | SESE |
| K961906 | UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 | Spectrum Medsystems Corp. | Nov 19, 1996 | SESE |
| K952780 | URINARY GEL DRAINAGE SYSTEM | P.A.M., Inc. | Dec 12, 1995 | SESE |
| K951597 | URINARY DRAINAGE BAG | Key Medical Services, Inc. | Aug 4, 1995 | SESE |
| K942753 | ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER | Researched, Novel Medical Devices (Rn/Md) | Nov 2, 1994 | SESE |
| K933126 | COMFORTCARE SYSTEM | Patsy J. Trisler, J.D. | Feb 25, 1994 | SESE |
| K930556 | NIGHT URINARY DRAINAGE BEDSIDE BAG | Ezmt Valve Co., Inc. | May 14, 1993 | SESE |
| K896695 | DYNA-FLO URINARY DRAINAGE BAG | Medline Industries, Inc. | May 2, 1990 | SESE |
| K901000 | URO TEX URINALS | Sierra Laboratories, Inc. | Mar 26, 1990 | SESE |
| K891178 | TECNOL SECURE-ALL TUBE HOLDER | Tecnol New Jersey Wound Care, Inc. | May 23, 1989 | SESE |
| K890465 | CLOSED SYSTEM URINARY DRAINAGE BAG | Cypress Medical Products, Ltd. | May 23, 1989 | SESE |
| K882714 | URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 | Lsl Industries, Inc. | Jan 31, 1989 | SESE |
| K780267 | CATH TRAY W/OUT CATHETER | Latex Ind., Inc. | Feb 24, 1978 | SESE |
| K772113 | URINARY DRAINAGE BAG 2D9017 | Travenol Laboratories, S.A. | Nov 16, 1977 | SESE |
Top Applicants
- Cypress Medical Products, Ltd. — 1 clearance
- Ezmt Valve Co., Inc. — 1 clearance
- Goulter Medical, Inc. — 1 clearance
- Key Medical Services, Inc. — 1 clearance
- Latex Ind., Inc. — 1 clearance
