Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)

The Unimed Reusable SpO2 Sensors (U403S-08) are finger-clip oxygen saturation and pulse rate monitoring devices for use in professional healthcare environments. They measure functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) non-invasively in adult patients weighing over 30 kg, for prescription use only under no-motion conditions.

The subject device uses two-wavelength relative optical absorption (660nm/905nm LEDs) with a DB9 connector and TPU-jacketed cable, featuring ISO 10993-compliant patient-contacting materials. It demonstrates identical performance specifications to the predicate: ±3% SpO2 accuracy (70-100%), ±3 bpm pulse rate accuracy (30-250 bpm), operating temperature 5-40°C, and 10-85% humidity tolerance. The main design difference is a soft-tip sensor configuration versus the predicate's finger clip design.

Non-clinical testing conformed to IEC 60601-1 (medical electrical equipment safety), IEC 60601-1-2 (electromagnetic disturbances), ISO 80601-2-61 (pulse oximeter requirements), and ISO 10993 biocompatibility standards (cytotoxicity, skin sensitization, skin irritation). Clinical validation used ISO 80601-2-61 and FDA guidance for pulse oximeter premarket submissions, with 12 adult volunteer subjects including adequate dark-pigmented representation.