FDA UDI
In Commercial Distribution
🇺🇸 United States
Ethos®
DI: B205CSECD1001
·
Model: ECD-100
·
CS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ethos®
- Primary DI
- B205CSECD1001
- Version / Model
- ECD-100
- Catalog Number
- CS-ECD-100
- Company Name
- CS MEDICAL, LLC
- Labeler DUNS
- 603864294
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-31
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 769df246-86bc-47b8-8dfe-8620334383b5
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PSW | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B205CSECD1001 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230381 | 000 |