Who else makes this device?

Name: NovaFlow C Ultrasonic Flowcomputer
Brand: NovaFlow C Ultrasonic Flowcomputer

Cardiovascular › MonitoringFlowmeter, Blood, Cardiovascular

NovaFlow C Ultrasonic Flowcomputer

The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems.…

Registry build 21.09.26

The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: – Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis – Perfusion, infusion, transfusion – Several shunt-applications

4manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code DPW
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Helen of Troy Macao Limited	Macau	Guangdong	Private-label distributor	11
Dongguan Mars Medical Products Co., Ltd.	Dongguan	Guangdong	Manufacturer	9
Onbo Electronic (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6

Record

Regulatory record for NovaFlow C Ultrasonic Flowcomputer
Listed by	Em-Tec GmbH, Germany
FDA product code	DPW
Device type	Flowmeter, Blood, Cardiovascular
Device class	Class 2
Regulation	21 CFR 870.2100
510(k)	K040909
Record published	2018-09-20

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for NovaFlow C Ultrasonic Flowcomputer
Catalogue number	Size	Status
11945		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Transonic	Transonic Systems, Inc.	627
SonoTT Vascular Probe	Em-Tec GmbH	12
BiDop 7 probe	Koven Technology, Inc.	8
Medistim MiraQ Cardiac System	Medistim ASA	6
Medistim MiraQ Vascular System	Medistim ASA	6
FlowMet™	Medtronic, Inc.	4
GEM Flow Coupler	Synovis Micro Companies Alliance	4
CooperSurgical®	Coopersurgical, Inc.	4
Medistim System Activation Card	Medistim ASA	3
811-BL 24V Foreign & Domestic	Parks Medical Electronics, Inc.	3
Medistim MiraQ Ultimate System	Medistim ASA	3
Dopplex	Huntleigh Healthcare Ltd.	3

Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K111730	2012-01-06
K040909	2004-04-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.