OGG · Humidifier Nebulizer Kit

Anesthesiology · 21 CFR 868.5450 · Class 2

Overview

Product CodeOGG
Device NameHumidifier Nebulizer Kit
Regulation21 CFR 868.5450
Device ClassClass 2
Review PanelAnesthesiology

Identification

A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

Classification Rationale

Class II (performance standards).

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Innolitics

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