21 CFR § 864.9205 - Blood and plasma warming device.

---
identifier: "/us/cfr/t21/s864.9205"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.9205 - Blood and plasma warming device."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.9205"
section_name: "Blood and plasma warming device."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 864.9205 Blood and plasma warming device.

(a) *Nonelectromagnetic blood or plasma warming device*—(1) *Identification.* A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.

(2) *Classification.* Class II (performance standards).

(b) *Electromagnetic blood and plasma warming device*—(1) *Identification.* An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.

(2) *Classfication.* Class III (premarket approval).

(c) *Date PMA or notice of completion of a PDP is required.* No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.

[45 FR 60642, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987]