21 CFR 868.5300 — Absorbent, Carbon-Dioxide
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5300
Identification
A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit.
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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CBL | Absorbent, Carbon-Dioxide | 1 | 5 |
