FIZE kUO Disposable Pediatric Kit

Basic Information

• Brand Name: FIZE kUO Disposable Pediatric Kit
• Primary DI: 07290019239208
• Version / Model: G2
• Catalog Number: FI-KT00-KU01-0008
• Company Name: FIZE RESEARCH LTD
• Labeler DUNS: 649273943
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-29
• Public Version: 1
• Public Version Date: 2025-05-07
• Public Version Status: New
• Public Device Record Key: 923f2c6d-7b77-43ef-b857-80ab3ac7fea2

Device Description

FIZE kUO Disposable Pediatric Kit catalog number of 1 pc: FI-KT00-KU01-0008 FIZE kUO Disposable Pediatric Kit catalog number of 10 pcs: FI-FG00-KU03-0004

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXY	Uroflowmeter	Gastroenterology, Urology	876.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47458	Urine monitoring system	An 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)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290019239205	GS1	box	10	In Commercial Distribution
Primary	07290019239208	GS1