FDA.reportPublic FDA data

NovaFlow C Ultrasonic Flowcomputer

Primary DI
04062114000280
Brand
NovaFlow C Ultrasonic Flowcomputer
Company
em-tec GmbH
Model
11945
Catalog number
11945
Device description
The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-onTransducer is indicated for the contact less volumetric measurement of liquid flowing throughtubing 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
Published
2018-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040909000SONO TT ULTRASONIC FLOWCOMPUTEREm-Tec GmbH2004-04-20DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04062114000280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04062114000280040621140002804062114000280

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, line-poweredA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49880692360info@em-tec.de

Regulatory Flags#

DUNS number
320025190
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04062114000013SonoTT FlowLab11916119162018-09-20
04062114000037Clamp-On Transducer11783117832018-09-20
04062114000044Clamp-On Transducer11767117672018-09-20
04062114000051Clamp-On Transducer11768117682018-09-20
04062114000068Clamp-On Transducer11782117822018-09-20
04062114000075Clamp-On Transducer12131121312018-09-20
04062114000082Clamp-On Transducer12133121332018-09-20
04062114000099Clamp-On Transducer12132121322018-09-20
04062114000105SonoTT Vascular Probe11342113422018-09-20
04062114000112SonoTT Vascular Probe11343113432018-09-20
04062114000129SonoTT Vascular Probe11344113442018-09-20
04062114000136SonoTT Vascular Probe11345113452018-09-20
04062114000143SonoTT Vascular Probe11939119392018-09-20
04062114000150SonoTT Vascular Probe11940119402018-09-20
04062114000167SonoTT Vascular Probe11346113462018-09-20
04062114000174SonoTT Vascular Probe11347113472018-09-20
04062114000181SonoTT Vascular Probe11348113482018-09-20
04062114000198SonoTT Vascular Probe11349113492018-09-20
04062114000204SonoTT Vascular Probe11941119412018-09-20
04062114000211SonoTT Vascular Probe11942119422018-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937029536CooperSurgical® Coopersurgical, Inc.DPW2026-04-10
00888937027815CooperSurgical® Coopersurgical, Inc.DPW2026-04-01
00888937027839CooperSurgical® Coopersurgical, Inc.DPW2026-04-01
00813079022664VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2025-11-27
00813079022671VascuChek Speaker DockREMINGTON MEDICAL, INC.DPW2025-11-27
00813079022688VascuChek KitREMINGTON MEDICAL, INC.DPW2025-11-27
00888937027822CooperSurgical® Coopersurgical, Inc.DPW2025-09-25
00627987360158Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
10627987360155Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
07070554102690Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
07070554103611Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
00813079022619VascuChek Surgical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022657VascuChek Clinical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
10813079022616VascuChek Surgical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022626VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022633VascuChek ChargerREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022640VascuChek KitREMINGTON MEDICAL, INC.DPW2024-08-23
10813079022654VascuChek Clinical ProbeREMINGTON MEDICAL, INC.DPW2024-08-23
07070554103444Medistim MiraQ Vascular SystemMedistim ASADPW2024-04-12
00817122020560VTI 8MHz TQI 2.0 Doppler TransceiverVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00817122020577Footswitch, MutingVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00817122020584Pole MountVASCULAR TECHNOLOGY, INCORPORATEDDPW2024-01-25
00627987360134Reprocess FloPatch1929803 Ontario CorpDPW2023-05-08
10627987360131Reprocess FloPatch1929803 Ontario CorpDPW2023-05-08
00627987360141Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
10627987360148Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
00627987360110Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10627987360117Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
00627987360127Acrylate Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10080196734290MedlineMEDLINE INDUSTRIES, INC.DPW2022-03-04