Biegler GmbH

Biegler GmbH specializes in conduction blood and fluid warming solutions, including standalone warmers like the BW685 and BW685S, as well as warmer sets designed for medical use. Their portfolio also includes automated intravenous pressure infusors, such as the automatic pressure infusor and Stivax, and extension sets for fluid administration. Additionally, they produce a device called the P-STIM, which appears to combine intravenous pressure infusion with stimulation capabilities.

Biegler GmbH is based in the United States. The company’s headquarters and operations are located within the country, though specific regional details are not provided.

Biegler GmbH’s devices are recorded in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track regulatory submissions and device identification for compliance purposes.

Biegler GmbH’s devices fall under three FDA classification categories: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Class U (unclassified devices that may require further evaluation). The classification depends on the specific device’s intended use and risk profile.

Biegler GmbH’s conduction blood/fluid warmers, such as the BW685 and BW685S, are designed to maintain or raise the temperature of fluids (like blood or intravenous solutions) during medical procedures. These devices use conduction heating to ensure precise temperature control, which is critical in transfusions or infusions to prevent complications like hypothermia. Their inclusion in Class I and Class II categories reflects varying levels of regulatory oversight based on their intended use and potential risks.