21 CFR 872.6100 — Warmer, Anesthetic Tube
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6100
Identification
An anesthetic warmer is an AC-powered device into which tubes containing anesthetic solution are intended to be placed to warm them prior to administration of the anesthetic.
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 § 872.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EFC | Warmer, Anesthetic Tube | 1 | 0 | |
| QGO | Composite Resin Warmer | 1 | 1 |