Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4780](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4780) → OJR — Vacuum Powered Body Fluid Collection Kit

# OJR · Vacuum Powered Body Fluid Collection Kit

_General, Plastic Surgery · 21 CFR 878.4780 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OJR

## Overview

- **Product Code:** OJR
- **Device Name:** Vacuum Powered Body Fluid Collection Kit
- **Regulation:** [21 CFR 878.4780](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4780)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OJR](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OJR)

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