Sono TT Ultrasonic Flowcomputer 11923

GUDID 04062114000266

The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of

em-tec GmbH

Noninvasive vascular ultrasound system, line-powered

• Primary Device ID: 04062114000266
• NIH Device Record Key: c1ef5278-a5bf-4c05-b004-5289a72a4c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sono TT Ultrasonic Flowcomputer
• Version Model Number: 11923
• Catalog Number: 11923
• Company DUNS: 320025190
• Company Name: em-tec GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49880692360
• Email: info@em-tec.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04062114000266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040909

FDA Product Code

• DPW: Flowmeter, Blood, Cardiovascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-20

On-Brand Devices [Sono TT Ultrasonic Flowcomputer]

• 04062114000297: The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is ind
• 04062114000266: The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is ind