{"data":{"id":"us/21-cfr-864.9195","jurisdiction":"us","citation":"21 CFR 864.9195","heading":"Blood mixing devices and blood weighing devices.","body":"(a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.\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":"674bbeead95b5aa4a74c0886eac558e70b05698b128560d4b35d3fee48444eee","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.9185","next":"us/21-cfr-864.9205"},"notice":"GroundRules: Original legal text. Not legal advice."}