Clamp-On Transducer - Clamp-on Transducer: The SonoTT Clamp-on - em-tec GmbH

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.

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More Product Details

Catalog Number

12133

Brand Name

Clamp-On Transducer

Version/Model Number

12133

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 2018

Issuing Agency

In GS1

Product Characteristics

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"

-

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 Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

3f39da63-c59d-4e44-8d1f-c12fa6d5fff8

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EM-TEC GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23