{"data":{"id":"us/21-cfr-864.9125","jurisdiction":"us","citation":"21 CFR 864.9125","heading":"Vacuum-assisted blood collection system.","body":"(a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.\n(b) Classification. Class I (general controls). The manual 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":"6edef4bbb76345653483783ba6af9d43b47b7740b664ef162faa10a3ca57ed81","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.9115","next":"us/21-cfr-864.9145"},"notice":"GroundRules: Original legal text. Not legal advice."}