FDA.reportPublic FDA data

Rivus

Primary DI
04650075336922
Brand
Rivus
Company
NEUROSOFT, OOO
Model
Rivus
Device description
The uroflowmeter is intended to quantify the flow characteristics of the lower urinary tract. The uroflowmetry is used for patients with urinary incontinence, abnormal urinary retention.
Published
2024-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EXYUroflowmeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXYUroflowmeterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04650075336922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04650075336922046500753369224650075336922

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic measurement systemAn assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
643212926
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04650075333273CloudTMS EdgeCooling unit2026-01-23
04650075337783CloudTMS EdgeMain unit2026-01-23
04650075339992RivusRivus2023-02-02
04650075335895CloudTMS Edge for OCDMain unit2024-01-12
04650075335932CoudTMS Edge for OCDExtra power supply unit2024-01-12
04650075335949CloudTMS Edge for OCDIrbis cooling unit2024-01-12
04650075333792CloudTMS for OCDMain unit2023-12-14
04650075333952CloudTMS for OCDCooling unit2023-12-14
04650075333969CloudTMS for OCDExtra power supply unit2023-12-14
04650075330036Neuro-AudioNeuro-Audio2016-09-22
04650075332078Steadys-StepSteadys-Step2023-08-14
04650075330081CloudEKGCloudEKG2016-09-21
04650075330296CloudTMSCloudTMS2017-12-21
04650075334003aTympaTymp2023-02-02
04650075331392Neuron-Spectrum-AMNeuron-Spectrum-AM2022-12-19
04650075333211Neuron-SpectrumCloudEEG2021-07-22
04650075330074FocusFocus2016-09-22
04650075330098Neuron-SpectrumNeuron-Spectrum-12016-09-22
04650075330104Neuron-SpectrumNeuron-Spectrum-22016-09-22
04650075330111Neuron-SpectrumNeuron-Spectrum-32016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00086000980061GleanBright Uro, IncEXY2025-09-23
00860009800601GleanBright Uro, IncEXY2025-09-23
00860009800632GleanBright Uro, IncEXY2025-09-23
00860009800649GleanBright Uro, IncEXY2025-09-23
00860009800656GleanBright Uro, IncEXY2025-09-23
07290019239017FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
07290019239024FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
07290019239031FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
07290019239208FIZE kUO Disposable Pediatric KitFIZE RESEARCH LTDEXY2025-04-29
07290019239215FIZE kUO Disposable Kit FIZE RESEARCH LTDEXY2025-04-29
07290019239284FIZE kUO Disposable Pediatrics kit, UrinemeterFIZE RESEARCH LTDEXY2025-04-29
07290019239291FIZE kUO Disposable Adult kit, UrinemeterFIZE RESEARCH LTDEXY2025-04-29
17290019239014FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
17290019239021FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
17290019239038FIZE kUO Console FIZE RESEARCH LTDEXY2025-04-29
17290019239205FIZE kUO Disposable Pediatric KitFIZE RESEARCH LTDEXY2025-04-29
17290019239212FIZE kUO Disposable Kit FIZE RESEARCH LTDEXY2025-04-29
17290019239281FIZE kUO Disposable Pediatrics kit, UrinemeterFIZE RESEARCH LTDEXY2025-04-29
17290019239298FIZE kUO Disposable Adult kit, UrinemeterFIZE RESEARCH LTDEXY2025-04-29
07290019239222FIZE kUO Disposable Pediatrics kit, UrinometerFIZE RESEARCH LTDEXY2025-04-28
07290019239239FIZE kUO Disposable kit PediatricsFIZE RESEARCH LTDEXY2025-04-28
07290019239246FIZE kUO Disposable KitFIZE RESEARCH LTDEXY2025-04-28
17290019239229FIZE kUO Disposable Pediatrics kit, UrinometerFIZE RESEARCH LTDEXY2025-04-28
17290019239236FIZE kUO Disposable kit PediatricsFIZE RESEARCH LTDEXY2025-04-28
17290019239243FIZE kUO Disposable KitFIZE RESEARCH LTDEXY2025-04-28
07290019239277FIZE kUO ConsoleFIZE RESEARCH LTDEXY2025-04-27
00860003478714TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESEXY2024-07-06
00860003478721TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESEXY2024-07-06
00860003478738TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESEXY2024-07-06
00860003478745TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESEXY2024-07-06