Identity
- Trade Name
- Sono TT Ultrasonic Flowcomputer FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Device Name
- The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: - Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis - Perfusion, infusion, transfusion - Several shunt-applications FDA UDI
- Model / Reference
- 11924 FDA UDI
- Description
- The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: - Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis - Perfusion, infusion, transfusion - Several shunt-applications FDA UDI
Identifiers
- Catalog Number
- 11924 FDA UDI
- Primary DI / UDI-DI
- 04062114000297 FDA UDI
- 510(k) Number
- K040909 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2100 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
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
Category: Noninvasive vascular ultrasound system, line-powered
Sono TT Ultrasonic Flowcomputer by em-tec GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K040909 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 4930fa50-8a0d-42f2-9031-f80698343d99 36 fields · synced May 30, 2026