CS Medical announces FDA 510(k) clearance of TD-8<sup>&reg;</sup>

Nov 02 2016

CS Medical announces FDA 510(k) clearance of TD-8^®

CS Medical is pleased to announce 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. Our core product, the TD 100, is an example of our commitment to innovation and to the health and safety of medical patients and staff. CS Medical is pleased to be your partner in providing proven and effective solutions for TEE Complete Care.

About CS Medical

CS Medical LLC has pioneered the automated disinfection process for Transesophageal ultrasound probes with the development and release of the TD 100^® Automated TEE Probe Disinfector. In 2005, the TD 100 was the first FDA cleared automated disinfection process with printed verification for Transesophageal ultrasound probes. During the disinfection process, the TEE probe receives high-level disinfection in (5) five minutes from TD-5^® or TD-8^® followed by (5) five complete rinse cycles before disinfection confirmation is acknowledged and a report is printed. The verification report indicates probe contact time with the high-level disinfectant as well as the average temperature of the single-use disinfectant during each cycle.

For more than 15 years and over 4 million high-level disinfections, the TD 100 Automated TEE Probe Disinfector has eliminated manual reprocessing of delicate and expensive TEE ultrasound probes while also providing a repeatable and FDA cleared disinfection process. The TEEClean^® Automated TEE Probe Cleaner Disinfector will continue the TD 100's work by automating the required cleaning process for the TEE probe before high-level disinfection. TEEClean, with electronic record data logging, printed verification reporting, FDA cleared cleaning, and high-level disinfection will be the standard of care for TEE ultrasound probes.

CS Medical's TEE Complete Care^® products provide quality device care and storage by minimizing healthcare operational costs, improving service readiness and increasing regulatory compliance.

CS Medical announces FDA 510(k) clearance of TD-8®

CS Medical announces FDA 510(k) clearance of TD-8®

CS Medical announces FDA 510(k) clearance of TD-8^®

CS Medical announces FDA 510(k) clearance of TD-8^®