Med-Link Temp-Pulse Oximeter

The Med-Link Temp-Pulse Oximeter is designed for use in clinical environments like hospitals, outpatient clinics, and emergency settings. Its real-time monitoring of arterial oxygen saturation (SpO₂) and pulse rate helps clinicians quickly assess a patient’s respiratory and circulatory status, enabling timely interventions for conditions like hypoxia or irregular heart rhythms.

Yes, the Med-Link Temp-Pulse Oximeter is supplied as either a single-use or reusable unit, depending on the specific model variant. Single-use models are ideal for reducing infection risk in high-turnover settings, while reusable models offer cost savings for facilities with robust sterilization protocols. The choice depends on facility policies and patient care needs.

The device has undergone FDA 510(k) clearance under the Traditional pathway (K202743) and complies with the Medical Device Directive (MDD). This means it is approved for use in the U.S. market under FDA regulations and can be marketed in the EU under the MDD framework, ensuring compliance with both jurisdictions’ requirements for cardiovascular monitoring instruments.

The device’s classification under product code DQA (cardiovascular-related monitoring) means it is regulated as a tool for assessing heart and blood vessel function, specifically for measuring SpO₂ and pulse rate. This classification ensures it meets stringent safety and performance standards for monitoring vital signs in patients with potential cardiovascular concerns, such as those in ICU, post-operative care, or chronic disease management.

While the device’s storage instructions aren’t detailed in the provided data, reusable models will require adherence to standard sterilization protocols (e.g., autoclave or chemical disinfection) to maintain safety and functionality. Single-use models should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve accuracy and sensor integrity until use.