21 CFR 868.5995 — Drain, Tee (Water Trap)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5995
Identification
A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.
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 |
|---|---|---|---|---|
| BYH | Drain, Tee (Water Trap) | 1 | 22 |
