21 CFR 868.5320 — Bag, Reservoir
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5320
Identification
A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.
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 |
|---|---|---|---|---|
| BTC | Bag, Reservoir | 1 | 19 |
