PLASMA FLEX
Device Facts
| Record ID | K811523 |
|---|---|
| Device Name | PLASMA FLEX |
| Applicant | Terumo America, Inc. |
| Product Code | KSR · Hematology |
| Decision Date | Sep 9, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.
