TEEClean®

GUDID B205CSTCD1000

The TEEClean automated cleaner disinfector is designed to provide enzymatic cleaning and high-level disinfection of Transesophageal (TEE) ultrasound probes. The system uses TEEZyme enzymatic cleaner as well as TD-5 or TD-8 disinfectants, which are designed to be used only with the TEEClean automated cleaner disinfector. The disinfectant bottles cannot be reused in the system.

CS MEDICAL, LLC

Ultrasound imaging transducer washer/disinfector

• Primary Device ID: B205CSTCD1000
• NIH Device Record Key: bf72fdf0-43ad-43c5-8ab6-f0dcbb7d88ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEEClean®
• Version Model Number: CS-TCD-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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B205CSTCD1000 [Primary]

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: 2019-10-03
• Device Publish Date: 2019-09-25

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®: 2023-08-08 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®: 2019-10-03The TEEClean automated cleaner disinfector is designed to provide enzymatic cleaning and high-level disinfection of Transesophageal (TEE) ultrasound probes. The system uses TEEZyme enzymatic cleaner as well as TD-5 or TD-8 disinfectants, which are designed to be used only with the TEEClean automated cleaner disinfector. The disinfectant bottles cannot be reused in the system.
• 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