DOUBLE ELUTRA-PACK UNIT
Device Facts
| Record ID | K760914 |
|---|---|
| Device Name | DOUBLE ELUTRA-PACK UNIT |
| Applicant | Travenol Laboratories, S.A. |
| Product Code | KSW · Hematology |
| Decision Date | Nov 23, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9145 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion.
