FDA UDI
In Commercial Distribution
🇺🇸 United States
TEEClean®
DI: B205CSTCD1000
·
Model: CS-TCD-100
·
CS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TEEClean®
- Primary DI
- B205CSTCD1000
- Version / Model
- CS-TCD-100
- Company Name
- CS MEDICAL, LLC
- Labeler DUNS
- 603864294
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-25
- Public Version
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- bf72fdf0-43ad-43c5-8ab6-f0dcbb7d88ea
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 | B205CSTCD1000 | HIBCC |