FDA.reportPublic FDA data

EasyFlo Base Unit

Primary DI
00890477000227
Brand
EasyFlo Base Unit
Company
SRS Medical Systems, Inc.
Model
84411314
Published
2018-06-25
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
00890477000227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00890477000227008904770002278904770002270890477000227

GMDN Terms#

Term, Definition table
TermDefinition
Urine flowmeter, reusableA device that is used to measure the flow and volume of urine from a patient during the course of normal urination in order to identify micturation disturbances. The device is usually used by healthcare professionals who instruct the patient to empty their bladder into the measuring chamber of the device; some types may be designed to be used by laymen. This device may use mechanical, electrical, or a combination for the measuring techniques and provide digital measurements such as total voided volume, volume at maximum flow, maximum flow rate, mean flow rate, flow time, and time of maximum flow. This is a reusable device.

Regulatory Flags#

DUNS number
796263598
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00890477000395Tri-Electrode Surface EMG730-0032026-03-04
00089047700395Tri-Electrode Surface EMG730-0032026-03-04
00890477000371EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)35700015S2026-01-21
00890477000388EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag)35700015S2026-01-21
00890477000364EasyFlo Console900-0442023-04-26
00890477000326CT3000 Pro Base Unit900-0402020-09-29
00890477000166Discovery Base Unit900-0102018-06-25
00890477000074Insight Discovery Thermal 900-0342021-08-20
00890477000081Insight Discovery PWP900-0362021-08-20
00890477000104Insight Discovery Dual Inclinometer900-024-22021-08-20
00890477000159Insight Discovery Algometer900-015-22021-08-20
00890477000173Insight Discovery PWP (w/cable)900-0232021-08-20
00890477000180EMG Sensor900-0262021-08-20
00890477000296Insight Discovery Thermal (w/cable)900-014-22021-08-20
00890477000098Insight Discovery EMG900-0372021-08-19
00890477000210UDS Pump213852021-08-20
00890477000142CT3000 Base Unit900-0272021-08-19
00890477000203Uroflow Scale900-0352021-08-19
00890477000258CT3000 ScaleCT3-022021-08-19
00890477000357UroFlow Scale900-0422021-08-17

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
04650075336922RivusNEUROSOFT, OOOEXY2024-12-20
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