FIZE kUO Disposable kit Adults

GUDID 07290019239093

FIZE RESEARCH LTD

Urine monitoring system
Primary Device ID07290019239093
NIH Device Record Key71ef4992-6f31-457f-a333-423b191fe3ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIZE kUO Disposable kit Adults
Version Model NumberFI-FGUS-KU03-0029
Company DUNS649273943
Company NameFIZE RESEARCH LTD
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290019239093 [Primary]

FDA Product Code

EXYUroflowmeter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-07
Device Publish Date2024-02-28

Devices Manufactured by FIZE RESEARCH LTD

17290019239014 - FIZE kUO Console 2025-05-07 FIZE kUO Console 5G
17290019239021 - FIZE kUO Console 2025-05-07 FIZE kUO Console 2.4G catalog number: FI-FG00-KU00-0005 FIZE kUO Console 2.4G with power box US catalog number: FKUO2.4G_PB_US F
17290019239038 - FIZE kUO Console 2025-05-07 FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US catalog number: FKUO5.0G_PB_US FIZE
17290019239205 - FIZE kUO Disposable Pediatric Kit2025-05-07 FIZE kUO Disposable Pediatric Kit catalog number of 1 pc: FI-KT00-KU01-0008 FIZE kUO Disposable Pediatric Kit catalog number of
17290019239212 - FIZE kUO Disposable Kit 2025-05-07 FIZE kUO Disposable Kit catalog number for 1 pc: FI-KT00-KU01-0007 FIZE kUO Disposable Kit catalog number for 10 pcs: FI-FG00-KU
17290019239281 - FIZE kUO Disposable Pediatrics kit, Urinemeter2025-05-07 FIZE kUO Disposable Pediatrics kit, Urinemeter catalog number of 1 pc: FI-KT00-KU01-0011 FIZE kUO Disposable Pediatrics kit,Urin
17290019239298 - FIZE kUO Disposable Adult kit, Urinemeter2025-05-07 FIZE kUO Disposable Adult kit, Urinemeter catalog number of 1 pc: FI-KT00-KU01-0010 FIZE kUO Disposable Adult kit, Urinemeter ca
17290019239229 - FIZE kUO Disposable Pediatrics kit, Urinometer2025-05-06 FIZE kUO Disposable Pediatrics kit, Urinometer catalog number for 1 pc: FI-KTUS-KU01-0155 FIZE kUO Disposable Pediatrics kit, Ur

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.