BSA · Warmer, Blood, Electromagnetic Radiation
Hematology · 21 CFR 864.9205 · Class 3
Overview
| Product Code | BSA |
|---|---|
| Device Name | Warmer, Blood, Electromagnetic Radiation |
| Regulation | 21 CFR 864.9205 |
| Device Class | Class 3 |
| Review Panel | Hematology |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
