FDA.reportPublic FDA data

FIZE kUO Disposable kit Pediatrics

Primary DI
17290019239236
Brand
FIZE kUO Disposable kit Pediatrics
Company
FIZE RESEARCH LTD
Model
G1
Catalog number
FI-KT00-KU01-0004
Device description
FIZE kUO Disposable kit Pediatrics Catalog Number for 1 Pc: FI-KT00-KU01-0004 FIZE kUO Disposable kit Pediatrics Catalog Number for 10 Pcs: FI-FG00-KU03-0002
Published
2025-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
17290019239236PackageGS110In Commercial Distribution
07290019239253PreviousGS10
07290019239239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001923923617290019239236
07290019239253072900192392537290019239253
07290019239239072900192392397290019239239

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

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
17290019239243FIZE kUO Disposable KitG1FI-KT00-KU01-00012025-04-28
07290019239277FIZE kUO Console2.4G1FI-FG00-KU00-00012025-04-27

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
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
00860003478745TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESEXY2024-07-06