21 CFR 868.5250 — Circulator, Breathing-Circuit
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5250
Identification
A breathing circuit circulator is a turbine device that is attached to a closed breathing circuit and that is intended to circulate anesthetic gases continuously by maintaining the unidirectional valves in an open position and reducing mechanical dead space and resistance in the breathing circuit.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CAG | Circulator, Breathing-Circuit | 2 | 0 | Life-Sustaining |
