NovaFlow C Ultrasonic Flowcomputer 11945

GUDID 04062114000280

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: 04062114000280
• NIH Device Record Key: 45a62840-123e-45de-b20b-88413927e3b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaFlow C Ultrasonic Flowcomputer
• Version Model Number: 11945
• Catalog Number: 11945
• 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	04062114000280 [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

Devices Manufactured by em-tec GmbH

• 04062114000013 - SonoTT FlowLab: 2018-10-22 The SonoTT FlowLab® is used for the volumetric measurement of liquid flowing through tubing systems (in combination with the So
• 04062114000037 - Clamp-On Transducer: 2018-10-22 Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to
• 04062114000044 - Clamp-On Transducer: 2018-10-22 Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to
• 04062114000051 - Clamp-On Transducer: 2018-10-22 "Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to
• 04062114000068 - Clamp-On Transducer: 2018-10-22 Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to
• 04062114000075 - Clamp-On Transducer: 2018-10-22 Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to
• 04062114000082 - Clamp-On Transducer: 2018-10-22 Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to
• 04062114000099 - Clamp-On Transducer: 2018-10-22 Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to