BLOOD WARMER (CODE 4R4305)
Device Facts
| Record ID | K760012 |
|---|---|
| Device Name | BLOOD WARMER (CODE 4R4305) |
| Applicant | Travenol Laboratories, S.A. |
| Product Code | BSB · Hematology |
| Decision Date | Jul 16, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9205 |
| Device Class | Class 2 |
Regulatory Classification
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.
