FDA Product Code NLF: Oximeter, Reprocessed

FDA product code NLF covers reprocessed pulse oximeters cleared for oxygen saturation monitoring after validated reprocessing.

Reusable pulse oximeter probes and sensors are reprocessed to restore sterility and functionality for reuse between patients. Reprocessed NLF devices must meet the same sensor calibration and accuracy requirements as original devices.

NLF devices are Class II medical devices, regulated under 21 CFR 870.2700 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Stryker Sustainability Solutions.