FDA.reportPublic FDA data

FIZE kUO Disposable kit Adults

Primary DI
07290019239093
Brand
FIZE kUO Disposable kit Adults
Company
FIZE RESEARCH LTD
Model
FI-FGUS-KU03-0029
Published
2024-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
07290019239093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019239093072900192390937290019239093

GMDN Terms#

Term, Definition table
TermDefinition
Urine monitoring systemAn assembly of devices intended to automatically and continuously monitor and display a patient's urine output (urine flow/volume). The system typically consists of a battery-powered, portable monitor with controls, digital display, alarms, and memory; an electronic (e.g., optical) urine output sensor; and a disposable urine collection container. The system is typically used in situations where fluid and renal management are critical to patient treatment and care [e.g., during diuresis monitoring in the intensive care unit (ICU)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649273943
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019239017FIZE kUO Console 5G1FI-FG00-KU00-00022025-04-29
07290019239024FIZE kUO Console 2.4G2FI-FG00-KU00-00052025-04-29
07290019239031FIZE kUO Console 5G2FI-FG00-KU00-00062025-04-29
07290019239208FIZE kUO Disposable Pediatric KitG2FI-KT00-KU01-00082025-04-29
07290019239215FIZE kUO Disposable Kit G2FI-KT00-KU01-00072025-04-29
07290019239284FIZE kUO Disposable Pediatrics kit, UrinemeterG2FI-KT00-KU01-00112025-04-29
07290019239291FIZE kUO Disposable Adult kit, UrinemeterG2FI-KT00-KU01-00102025-04-29
17290019239014FIZE kUO Console 5G1FI-FG00-KU00-00022025-04-29
17290019239021FIZE kUO Console 2.4G2FI-FG00-KU00-00052025-04-29
17290019239038FIZE kUO Console 5G2FI-FG00-KU00-00062025-04-29
17290019239205FIZE kUO Disposable Pediatric KitG2FI-KT00-KU01-00082025-04-29
17290019239212FIZE kUO Disposable Kit G2FI-KT00-KU01-00072025-04-29
17290019239281FIZE kUO Disposable Pediatrics kit, UrinemeterG2FI-KT00-KU01-00112025-04-29
17290019239298FIZE kUO Disposable Adult kit, UrinemeterG2FI-KT00-KU01-00102025-04-29
07290019239222FIZE kUO Disposable Pediatrics kit, UrinometerG1FI-KTUS-KU01-01552025-04-28
07290019239239FIZE kUO Disposable kit PediatricsG1FI-KT00-KU01-00042025-04-28
07290019239246FIZE kUO Disposable KitG1FI-KT00-KU01-00012025-04-28
17290019239229FIZE kUO Disposable Pediatrics kit, UrinometerG1FI-KTUS-KU01-01552025-04-28
17290019239236FIZE kUO Disposable kit PediatricsG1FI-KT00-KU01-00042025-04-28
17290019239243FIZE kUO Disposable KitG1FI-KT00-KU01-00012025-04-28

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