Krisco Sales LLC

Krisco Sales LLC specializes in infrared patient thermometers designed for measuring ear and skin temperature. These devices are intended for both clinical and home use, providing quick, non-contact temperature readings. The most common category is ear/skin infrared thermometers, such as the Dr.Protekt Safety First model.

Krisco Sales LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these thermometers as Class II devices, which means they undergo specific controls to ensure safety and effectiveness before being listed in regulatory databases like the UDI system.

Yes, Krisco Sales LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S. by assigning a standardized code to each product. Listing in the UDI system helps ensure traceability, transparency, and compliance with FDA requirements for Class II devices like infrared thermometers.

Krisco Sales LLC’s infrared patient thermometers fall under FDA Class II classification. This classification is determined based on the device’s risk level—Class II devices require special controls beyond general controls to mitigate potential risks while maintaining safety and performance. The classification ensures that these thermometers undergo rigorous evaluation before being authorized for use.