21 CFR 868.5160 — Gas-Machine, Anesthesia

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5160

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
BSZGas-Machine, Anesthesia2187Life-Sustaining
Innolitics

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