Identity
- Trade Name
- Clamp-On Transducer FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to the tubing by a simple click closure device and measurements are made non-invasively. The measurement method can be used for extracorporeal circulation systems such as heart-lung machines or ECMO/ECLS applications. The sensors are available in different sizes for all conventional tubing sizes. A customer-specific calibration of the sensor guarantees the highest measurement precision and complete reliability. FDA UDI
- Model / Reference
- 12132 FDA UDI
- Description
- Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to the tubing by a simple click closure device and measurements are made non-invasively. The measurement method can be used for extracorporeal circulation systems such as heart-lung machines or ECMO/ECLS applications. The sensors are available in different sizes for all conventional tubing sizes. A customer-specific calibration of the sensor guarantees the highest measurement precision and complete reliability. FDA UDI
Identifiers
- Catalog Number
- 12132 FDA UDI
- Primary DI / UDI-DI
- 04062114000099 FDA UDI
- 510(k) Number
- K111730 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- Not 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
No
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
Clamp-On Transducer by em-tec GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K111730 also covers:
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
- em-tec GmbH
Sources (1)
- FDA UDI 1f5f8127-7f02-43c1-a9a0-56355ba1eb5c 37 fields · synced Jun 8, 2026