21 CFR 868.5895 — Ventilator, Continuous, Facility Use

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5895

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
CBKVentilator, Continuous, Facility Use2504Life-Sustaining
MNSVentilator, Continuous, Non-Life-Supporting247
MNTSv70 Ventilator225Life-Sustaining
MODAccessory To Continuous Ventilator (Respirator)2133rd Party
NOUContinuous, Ventilator, Home Use27Life-Sustaining
NQYVentilator, Continuous, Minimal Ventilatory Support, Home Use20Life-Sustaining
ONZMechanical Ventilator26
SGRNoninvasive Positive Airway Pressure System, Facility Use22
Innolitics

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