FDA.reportPublic FDA data

DANFLOW Wave - Uroflowmeter

Primary DI
08594211571579
Brand
DANFLOW Wave - Uroflowmeter
Company
MEDKONSULT medical technology s.r.o.
Model
FU1110-BT
Catalog number
FU1110-BT
Device description
Bluetooth DANFLOW Wave uroflowmeter distributed as spare part
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08594211571579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08594211571579085942115715798594211571579

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.

Regulatory Flags#

DUNS number
361814147
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08594211571524EMG moduleMU5006-60MU5006-602026-10-15
08594211571548EMG module for UROMIC HarmonyFU9007-60FU9007-602026-10-15
08594211571562DANFLOW Wave - UroflowmeterFU1110-915FU1110-9152026-10-15
08594211571586DANFLOW Chord - UroflowmeterFU1210FU12102026-10-15
08594211570466ATMOS Air-Charged Pressure SensorPS11-01A252024-11-06
08594211570473ATMOS Air-Charged Pressure SensorPS11-01R252024-11-06
08594211570480ATMOS Air-Charged Pressure SensorPS11-01U252024-11-06
08594211570497ATMOS Air-Charged Pressure SensorPS11-01V252024-11-06
08594211570541ATMOS Air-Charged Pressure SensorPS11-02A052024-11-06
08594211570558ATMOS Air-Charged Pressure SensorPS11-02R052024-11-06
08594211570565ATMOS Air-Charged Pressure SensorPS11-02U052024-11-06
08594211570572ATMOS Air-Charged Pressure SensorPS11-02V052024-11-06
08594211570664ATMOS Air-Charged Pressure SensorPS11-11A052024-11-06
08594211570671ATMOS Air-Charged Pressure SensorPS11-11A252024-11-06
08594211570688ATMOS Air-Charged Pressure SensorPS11-11R052024-11-06
08594211570695ATMOS Air-Charged Pressure SensorPS11-11R252024-11-06
08594211570701ATMOS Air-Charged Pressure SensorPS11-11U052024-11-06
08594211570718ATMOS Air-Charged Pressure SensorPS11-11U252024-11-06
08594211570725ATMOS Air-Charged Pressure SensorPS11-11V052024-11-06
08594211570732ATMOS Air-Charged Pressure SensorPS11-11V252024-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08594211571562DANFLOW Wave - UroflowmeterMEDKONSULT medical technology s.r.o.EXY2026-10-15
08594211571586DANFLOW Chord - UroflowmeterMEDKONSULT medical technology s.r.o.EXY2026-10-15
00860009800663GleanBright Uro, IncEXY2026-07-29
00860009800670GleanBright Uro, IncEXY2026-07-29
00199874903484Emano FlowEmano Metrics Inc.EXY2026-06-16
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