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e-CFR data is current as of October 27, 2020

Title 21Chapter ISubchapter HPart 864Subpart J → §864.9205


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products


§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]

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