Duns Number:320025190
Device Description: Clamp-on Transducer: The SonoTT Clamp-on Transducermeasures flow in extracorporeal tubing Clamp-on Transducer: The SonoTT Clamp-on Transducermeasures flow in extracorporeal tubing systems. The sensor isclamped on to the tubing by a simple click closure device andmeasurements are made non-invasively. The measurementmethod can be used for extracorporeal circulation systems suchas heart-lung machines or ECMO/ECLS applications. The sensorsare available in different sizes for all conventional tubingsizes. A customer-specific calibration of the sensor guaranteesthe highest measurement precision and complete reliability.
Catalog Number
12131
Brand Name
Clamp-On Transducer
Version/Model Number
12131
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111730
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
4060e84d-0c46-4944-bf19-3a7c5bcf70db
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |