21 CFR 868.5915 — Ventilator, Emergency, Manual (Resuscitator)

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5915

Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
BTMVentilator, Emergency, Manual (Resuscitator)22093rd Party, Life-Sustaining
OEVCardiopulmonary Resuscitation Aid Kit20
Innolitics

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