FIZE kUO Console

GUDID 07290019239000

FIZE RESEARCH LTD

Urine monitoring system

• Primary Device ID: 07290019239000
• NIH Device Record Key: 90daca5f-715a-4913-95d3-8dc9119d8905
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIZE kUO Console
• Version Model Number: FI-FGUS-KU00-0001
• Company DUNS: 649273943
• Company Name: FIZE RESEARCH LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019239000 [Primary]

FDA Product Code

• EXY: Uroflowmeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-07
• Device Publish Date: 2024-02-28

On-Brand Devices [FIZE kUO Console]

• 07290019239000: FI-FGUS-KU00-0001
• 07290019239277: FIZE kUO Console 2.4G
• 17290019239038: FIZE kUO Console 5G catalog number: FI-FG00-KU00-0006 FIZE kUO console 5G with power box US cata
• 17290019239021: FIZE kUO Console 2.4G catalog number: FI-FG00-KU00-0005 FIZE kUO Console 2.4G with power box US
• 17290019239014: FIZE kUO Console 5G