21 CFR 864.9750 — Device, Heat-Sealing
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9750
Identification
A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KSD | Device, Heat-Sealing | 1 | 1 |
