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Biegler BW385L Blood & Infusion Warmer

by Biegler Medical Products, Inc.

510(k) K954769

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954769 Date8 Aug 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LGZ
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Biegler BW385L Blood and Infusion Warmer is a thermal device designed to warm blood and infusion fluids to physiological temperatures. It is classified as a thermal warmer for infusion fluids, ensuring safe and effective temperature control to mitigate complications associated with hypothermia during transfusions and infusions.

This reusable device is intended for use in general hospital settings and is not MRI-safe. It holds FDA 510(k) clearance under the traditional pathway and is classified under product code LGZ. Storage and handling follow standard hospital protocols for reusable medical instruments, adhering to regulatory standards for thermal management of infusion fluids.

Biegler BW385L Blood and Infusion Warmer

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Biegler BW385L Blood & Infusion Warmer used for?

    The Biegler BW385L Blood & Infusion Warmer is designed to maintain and elevate the temperature of blood and infusion fluids to physiological levels during transfusions and infusions. This helps prevent complications associated with hypothermia, such as metabolic disturbances, coagulopathy, and increased infection risk, ensuring safer patient care in hospital settings.

  • Is the Biegler BW385L Blood & Infusion Warmer reusable or single-use?

    The Biegler BW385L Blood & Infusion Warmer is a reusable device. It is intended for repeated use in hospital environments, following standard protocols for cleaning, disinfection, and sterilization of reusable medical instruments to maintain safety and functionality.

  • What regulatory approval does the Biegler BW385L Blood & Infusion Warmer hold?

    The Biegler BW385L Blood & Infusion Warmer holds FDA 510(k) clearance under the traditional pathway, classified under product code LGZ. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets applicable regulatory standards for thermal management of infusion fluids.

  • Can the Biegler BW385L Blood & Infusion Warmer be used in MRI environments?

    No, the Biegler BW385L Blood & Infusion Warmer is not MRI-safe. It should only be used in non-MRI environments to avoid interference or safety risks associated with magnetic resonance imaging.

  • How should the Biegler BW385L Blood & Infusion Warmer be stored and handled?

    The Biegler BW385L Blood & Infusion Warmer should be stored and handled according to standard hospital protocols for reusable medical instruments. This includes proper cleaning, disinfection, and sterilization procedures to ensure it remains safe and functional for repeated use. Adherence to these protocols helps maintain regulatory compliance and device integrity.