Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9205](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9205) → BSA — Warmer, Blood, Electromagnetic Radiation

# BSA · Warmer, Blood, Electromagnetic Radiation

_Hematology · 21 CFR 864.9205 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSA

## Overview

- **Product Code:** BSA
- **Device Name:** Warmer, Blood, Electromagnetic Radiation
- **Regulation:** [21 CFR 864.9205](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9205)
- **Device Class:** 3
- **Review Panel:** [Hematology](/submissions/HE)

## 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. 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.

## Classification Rationale

Nonelectromagnetic blood and plasma warming device: Class II (performance standards). Electromagnetic blood and plasma warming device: Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSA](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSA)

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