21 CFR 868.5240 — Circuit, Breathing (W Connector, Adaptor, Y Piece)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5240
Identification
An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
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 |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 184 | |
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | 1 | 0 |
