KZL · Device, Warming. Blood And Plasma
Hematology · 21 CFR 864.9205 · Class 2
Overview
| Product Code | KZL |
|---|---|
| Device Name | Device, Warming. Blood And Plasma |
| Regulation | 21 CFR 864.9205 |
| Device Class | Class 2 |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K813489 | ROCKING/CIRCULATING CYTO-THERM II 3570 | Cryosan, Inc. | Mar 4, 1982 | SESE |
| K812311 | CIRCULATING CYTO-THERMS | Cryosan, Inc. | Sep 16, 1981 | SESE |
| K800699 | FLO TEM (FLUID WARNER) | Chroma Products, Inc. | May 8, 1980 | SESE |
| K790936 | MODEL 114 TREONIC H150 HAEMOHEATER | Vickers America Medical Corp. | Sep 4, 1979 | SESE |
Top Applicants
- Cryosan, Inc. — 2 clearances
- Chroma Products, Inc. — 1 clearance
- Vickers America Medical Corp. — 1 clearance
