Ethos®

Primary DI
B205CSECD1001
Brand
Ethos®
Company
CS MEDICAL, LLC
Model
ECD-100
Catalog number
CS-ECD-100
Device description
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.
Published
2023-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, LiquidRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230381000Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical IndicatorCs Medical, LLC2023-06-07PSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B205CSECD1001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging transducer washer-disinfector (chemical)A dedicated electrically-powered unit intended to be used to wash and disinfect ultrasound imaging transducers with the use of appropriate cleaning methods and chemical disinfection. It is typically a stand-alone unit with a washing/disinfecting chamber designed to accept an ultrasound imaging transducer (probe).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603864294
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B205CS2027901QwikCheck®202790CS-2027902023-07-31
B205CSTD2001TD 200®TD 200CS-TD-2002020-04-15
B205CSTCD1000TEEClean®CS-TCD-1002019-09-25
B205TD100A0TD 100®TD 100CS-TD-1002016-09-16
B205TD100B0TD 100®TD 100CS-TD-1002016-11-11
B205CSAQ31AquaCide®AQ-3CS-AQ-32023-07-31
B205CSTD121TD-12®TD-12CS-TD-122020-04-15
B205TD8A1TD-8®TD-8CS-TD-82016-11-11
B205TD5A1TD-5®TD-5CS-TD-52016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B205CSTD2001TD 200®CS MEDICAL, LLCPSW2020-04-15
B205CSTCD1000TEEClean®CS MEDICAL, LLCPSW2019-09-25