OJR · Vacuum Powered Body Fluid Collection Kit

General, Plastic Surgery · 21 CFR 878.4780 · Class 2

Overview

Product CodeOJR
Device NameVacuum Powered Body Fluid Collection Kit
Regulation21 CFR 878.4780
Device ClassClass 2
Review PanelGeneral, 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.

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Innolitics

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