Identity
- Trade Name
- TEEClean® FDA UDI
- Generic Name
- Ultrasound imaging transducer washer-disinfector (chemical) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CS-TCD-100 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B205CSTCD1000 FDA UDI
- FDA Product Code
- PSW FDA UDI
- GMDN Term
- Ultrasound imaging transducer washer-disinfector (chemical) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasound imaging transducer washer-disinfector (chemical)
TEEClean® by Cs Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cs Medical Llc
Sources (1)
- FDA UDI bf72fdf0-43ad-43c5-8ab6-f0dcbb7d88ea 33 fields · synced May 31, 2026