AccessGUDID - DEVICE: Clamp-On Transducer (04062114000099)

GUDID

Device Identifier (DI) Information

Brand Name: Clamp-On Transducer
Version or Model: 12132
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12132
Company Name: em-tec GmbH

Primary DI Number: 04062114000099
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 320025190 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61422	Noninvasive vascular ultrasound system, line-powered	A mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111730	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1f5f8127-7f02-43c1-a9a0-56355ba1eb5c
Public Version Date: October 22, 2018
Public Version Number: 1
DI Record Publish Date: September 20, 2018