---
kind: "section"
citation: "21 C.F.R. § 864.9205"
title: "21"
number: "864.9205"
heading: "Blood and plasma warming device."
url: "https://uscodex.org/cfr/21/864.9205"
---

# §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)](#b-1). See [§ 864.3](/cfr/21/864.3.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

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