CS Medical announces FDA 510(k) clearance of a new single-use, high-level disinfectant chemistry for the TD 100® Automated TEE Ultrasound Probe Disinfector. The FDA cleared high-level disinfectant TD-8® is OPA based and delivers a 5-minute high-level disinfection for TEE probes. The disinfectant will operate in the TD 100® identically to TD-5®, which was previously the only FDA cleared high-level disinfectant for the TD 100®.
CS Medical’s president, Mark Leath, stated, “I am pleased and excited to bring this additional high-level disinfectant solution to the healthcare market. We, at CS Medical, hope this product will continue to exceed both current and future customer expectations. I am extremely proud of our technical team for the development and delivery of this new high-level disinfectant chemistry.”
For more than 10 years, CS Medical has provided the TD 100® Automated TEE Ultrasound Probe Disinfector to healthcare facilities throughout the United States. To date, the TD 100® has completed over 2.3 million successful disinfections with TD-5® and continues to provide validated and repeatable high-level disinfection for “dirty” TEE probes.
CS Medical is focused on all aspects of TEE ultrasound probe care with products like TEEZyme™ enzymatic sponges, QwikDry™ TEE drying cloths, electrical leakage testing, and HEPA filtered ultrasound probe storage.
Source: CS Medical LLC