OJR · Vacuum Powered Body Fluid Collection Kit
General, Plastic Surgery · 21 CFR 878.4780 · Class 2
Overview
| Product Code | OJR |
|---|---|
| Device Name | Vacuum Powered Body Fluid Collection Kit |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.