21 CFR 864.9205 — Warmer, Blood, Electromagnetic Radiation
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9205
Identification
A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.
Classification Rationale
Nonelectromagnetic blood and plasma warming device: Class II (performance standards). Electromagnetic blood and plasma warming device: Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BSA | Warmer, Blood, Electromagnetic Radiation | 3 | 0 | |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | 2 | 14 | |
| KZL | Device, Warming. Blood And Plasma | 2 | 4 |
