SonoTT Vascular Probe
The SonoTT Vascular Probe measures blood volume flow during surgery when connected to the SonoTT FlowLab system. It supports the assessment of blood flow during cardiovascular, vascular and…
The SonoTT Vascular Probe measures blood volume flow during surgery when connected to the SonoTT FlowLab system. It supports the assessment of blood flow during cardiovascular, vascular and transplantation interventions. The probe is intended for use by qualified medical personnel.
The measurement uses the ultrasound transit-time principle. The vascular probe provides the vessel measurement component, while the connected FlowLab unit processes and displays the flow information for the procedure.
Listed Item
High quality workmanship Ultrasonic Flow Probes for the measurement of blood flow in vessels and grafts. The probes are showing excellent accuracy and stability. Calibration data are stored in the probe. The probes can be manually and automatically cleaned and disinfected and sterilized with steam, ethylene oxide (EtO), low temperature steam and form – aldehyde sterilisation (LTSF) and low temperature plasma (LTP). We support up to 50 sterilisation cycles
Patient Contact
The vascular probe is intended for transient use with continuous patient contact lasting less than 60 minutes. The system’s stated patient population includes adults and children, excluding prenatal fetal and neonatal applications.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
| Dongguan Mars Medical Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Em-Tec GmbH, Germany |
|---|---|
| FDA product code | DPW |
| Device type | Flowmeter, Blood, Cardiovascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2100 |
| 510(k) | K111730 |
| Record published | 2018-09-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Ethylene Oxide |
| Label carries | expiry date, manufacturing date, serial number |
| Distribution end date | 2018-09-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11349 | Withdrawn | |
| 11347 | Withdrawn | |
| 11940 | Withdrawn | |
| 11941 | Withdrawn | |
| 11346 | Withdrawn | |
| 11939 | Withdrawn | |
| 11343 | Withdrawn | |
| 11942 | Withdrawn | |
| 11348 | Withdrawn | |
| 11345 | Withdrawn | |
| 11344 | Withdrawn | |
| 11342 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transonic | Transonic Systems, Inc. | 627 |
| BiDop 7 probe | Koven Technology, Inc. | 8 |
| Medistim MiraQ Cardiac System | Medistim ASA | 6 |
| Medistim MiraQ Vascular System | Medistim ASA | 6 |
| FlowMet™ | Medtronic, Inc. | 4 |
| GEM Flow Coupler | Synovis Micro Companies Alliance | 4 |
| CooperSurgical® | Coopersurgical, Inc. | 4 |
| Medistim System Activation Card | Medistim ASA | 3 |
| 811-BL 24V Foreign & Domestic | Parks Medical Electronics, Inc. | 3 |
| Medistim MiraQ Ultimate System | Medistim ASA | 3 |
| Dopplex | Huntleigh Healthcare Ltd. | 3 |
| VascuChek Transceiver | Remington Medical, Inc. | 2 |
Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111730 | 2012-01-06 |
| K040909 | 2004-04-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.