← Product Code [BSB](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB) · K760012

# BLOOD WARMER (CODE 4R4305) (K760012)

_Travenol Laboratories, S.A. · BSB · Jul 16, 1976 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K760012

## Device Facts

- **Applicant:** Travenol Laboratories, S.A.
- **Product Code:** [BSB](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB.md)
- **Decision Date:** Jul 16, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9205
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory 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.

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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/BSB/K760012](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K760012)

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