Ethos® CS-ECD-100

GUDID B205CSECD1001

The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The system uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfector. The disinfectant bottles cannot be reused in the system. The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.

CS MEDICAL, LLC

Ultrasound imaging transducer washer-disinfector (chemical)

• Primary Device ID: B205CSECD1001
• NIH Device Record Key: 769df246-86bc-47b8-8dfe-8620334383b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethos®
• Version Model Number: ECD-100
• Catalog Number: CS-ECD-100
• Company DUNS: 603864294
• Company Name: CS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B205CSECD1001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230381

FDA Product Code

• PSW: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-08
• Device Publish Date: 2023-07-31

Devices Manufactured by CS MEDICAL, LLC

• B205CS2027901 - QwikCheck®: 2023-08-08 The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingred
• B205CSAQ31 - AquaCide®: 2023-08-08 PAA Cleaner High-Level Disinfectant
• B205CSECD1001 - Ethos®: 2023-08-08The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The system uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfector. The disinfectant bottles cannot be reused in the system. The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.
• B205CSECD1001 - Ethos®: 2023-08-08 The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface
• B205CSTD121 - TD-12®: 2020-04-23 PAA High-Level Disinfectant
• B205CSTD2001 - TD 200®: 2020-04-23 TD 200® Automated TEE Probe Disinfector
• B205CSTCD1000 - TEEClean®: 2019-10-03 The TEEClean automated cleaner disinfector is designed to provide enzymatic cleaning and high-level disinfection of Transesophag
• B205TD100A0 - TD 100®: 2019-04-09 TD 100® Automated TEE Probe Disinfector
• B205TD100B0 - TD 100®: 2019-04-09 TD 100® Automated TEE Probe Disinfector