AccessGUDID - DEVICE: Ethos® (B205CSECD1001)

GUDID

Device Identifier (DI) Information

Brand Name: Ethos®
Version or Model: ECD-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS-ECD-100
Company Name: CS MEDICAL, LLC

Primary DI Number: B205CSECD1001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 603864294 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61673	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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PSW	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230381	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 769df246-86bc-47b8-8dfe-8620334383b5
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: July 31, 2023