FLO TEM (FLUID WARNER)
Device Facts
| Record ID | K800699 |
|---|---|
| Device Name | FLO TEM (FLUID WARNER) |
| Applicant | Chroma Products, Inc. |
| Product Code | KZL · Hematology |
| Decision Date | May 8, 1980 |
| 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.
