{"data":{"id":"us/21-cfr-864.9750","jurisdiction":"us","citation":"21 CFR 864.9750","heading":"Heat-sealing device.","body":"(a) Identification. A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.\n(b) Classification. 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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"41f6c9c764781905ef70f61c2577b335a217caa896b2b3d88cb487675c83e75f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.9700","next":"us/21-cfr-864.9875"},"notice":"GroundRules: Original legal text. Not legal advice."}