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. The TD 100 is 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 followed by (5) five complete rinse cycles before disinfection confirmation is acknowledged and a report is printed. The verification report indicates probe contact time to the high level disinfectant as well as the average disinfectant temperature of the single-use disinfectant during each disinfection cycle.

The TD 100 Automated TEE Probe Disinfector, for more than 10 years, has eliminated manual reprocessing of delicate and expensive TEE ultrasound probes while providing a repeatable and FDA cleared disinfection process.

CS Medical’s products provide quality device care and storage by minimizing healthcare operational costs, improving service readiness and increasing regulatory compliance.

Copies of the CS Medical 2016 catalog can be requested here: https://www.csmedicalllc.com/contact/catalog.php

For more information on TD-8 High-Level Disinfectant visit: TD-8 High-Level Disinfectant.