PLASMA POOLER HEAT SEALER
Device Facts
| Record ID | K820301 |
|---|---|
| Device Name | PLASMA POOLER HEAT SEALER |
| Applicant | North American Biologicals, Inc. |
| Product Code | KSD · Hematology |
| Decision Date | Apr 9, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9750 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.