Pulse Oximeter

The MD300CI series and the OX200 are both pulse oximeters from Beijing Choice Electronic Technology Co., Ltd., but they belong to separate model lines. The MD300CI series is part of a broader range (including MD300CN1, MD300CN3, MD300C5, MD300C2, and MD300C1), while the OX200 is a distinct model. Neither the data nor specifications provided detail functional or performance distinctions between these models, so their differences would require further clarification from the manufacturer. Both are non-sterile, single-use devices for measuring oxygen saturation (SpO₂) and pulse rate.

This pulse oximeter is classified as non-sterile, meaning it is not intended for use in sterile procedures or on sterile body sites. Storage should follow standard protocols for non-sterile medical devices, which typically involve keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is also non-reusable and designed for single-use, it should not be reprocessed or reused after one application. Proper handling ensures accuracy and avoids contamination risks.

The data does not specify whether this pulse oximeter is MRI-safe. If MRI compatibility is required, this device should not be used in an MRI environment without confirmation from the manufacturer. For MRI-compatible monitoring, alternatives like specialized MRI-safe pulse oximeters or other non-metallic monitoring devices would need to be selected. Always verify MRI safety with the manufacturer or device documentation before use.

This pulse oximeter has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). The FDA clearance indicates it meets U.S. standards for safety and effectiveness, while MDR compliance ensures it adheres to EU requirements. These pathways allow its use in both the U.S. and EU markets, but clinicians or buyers should always verify local regulatory compliance and any additional market-specific requirements before procurement or use.

This pulse oximeter is not labeled as latex-free, so it may contain latex or latex-derived materials. For patients with latex allergies, this device should be avoided unless confirmed latex-free by the manufacturer. If latex sensitivity is a concern, alternatives with explicit latex-free claims should be selected. Always check the device packaging or consult the manufacturer for material composition details.