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 five 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 U.S. 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. The core product, the TD 100, is an example of CS Medical’s 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.