21 CFR 868.5310 — Absorber, Carbon-Dioxide

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5310

Identification

A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain.

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
BSFAbsorber, Carbon-Dioxide18
Innolitics

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