FNY · Basin, Emesis
General Hospital · 21 CFR 880.6730 · Class 1
Overview
| Product Code | FNY |
|---|---|
| Device Name | Basin, Emesis |
| Regulation | 21 CFR 880.6730 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832826 | AAP DOSIMETRY RELEASE OR BASIN SETS | American Hospital Supply Corp. | Apr 23, 1984 | SESE |
| K802538 | BASIN PACK | Texas Medical Products, Inc. | Oct 31, 1980 | SESE |
| K800440 | STERILE SPONGE BOWLS | Premium Plastics, Inc. | Apr 29, 1980 | SESE |
| K792625 | STERILIZATION PROCESS/PLACENTA BASIN | Procter & Gamble Mfg. Co. | Jan 16, 1980 | SESE |
| K771733 | 8 EMESIS BASIN | Bemis Health Care | Sep 28, 1977 | SESE |
| K760495 | BASIN, RECTANGULAR WASH | Landmark Plastics | Nov 12, 1976 | SESE |
| K760494 | BASIN, ROUND WASH | Landmark Plastics | Nov 12, 1976 | SESE |
| K760492 | BASIN, LARGE OR SMALL | Landmark Plastics | Nov 12, 1976 | SESE |
| K760085 | BASIN, STERILE (#3200) | Concord Laboratories, Inc. | Jul 20, 1976 | SESE |
Top Applicants
- Landmark Plastics — 3 clearances
- American Hospital Supply Corp. — 1 clearance
- Bemis Health Care — 1 clearance
- Concord Laboratories, Inc. — 1 clearance
- Premium Plastics, Inc. — 1 clearance
