§ 864.9205. Blood and plasma warming device.
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/us/cfr/t21/s§ 864.9205·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]