21 CFR 868.5905 — Ventilator, Non-Continuous (Respirator)

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5905

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
BZDVentilator, Non-Continuous (Respirator)2456
NFBConserver, Oxygen2713rd Party
NHJDevice, Positive Pressure Breathing, Intermittent224
NHKResuscitator, Manual, Non Self-Inflating210Life-Sustaining
NMCMask, Ventilator, Non-Continuous, Reprocessed20
Innolitics

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