21 CFR 868.5600 — Mask, Oxygen, Low Concentration, Venturi

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5600

Identification

A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
BYFMask, Oxygen, Low Concentration, Venturi119
Innolitics

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