Glean

Basic Information

• Brand Name: Glean
• Primary DI: 00860009800625
• Version / Model: UFM-1000
• Catalog Number: UFM-1000
• Company Name: Bright Uro, Inc
• Labeler DUNS: 117955543
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-23
• Public Version: 1
• Public Version Date: 2025-10-01
• Public Version Status: New
• Public Device Record Key: 083207f7-55c1-4aa1-a977-3599e196c29d

Device Description

Glean Uroflowmeter

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXQ	Cystometer, Electrical Recording	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63634	Multi-parameter urinary monitoring system control unit	An electrically-powered component of a multi-parameter urinary monitoring system intended to process and display measurements of urinary output, intra-abdominal pressure (via intra-bladder pressure) and core temperature (via intra-bladder temperature). It is a control unit with a monitor connected to a dedicated disposable catheter set (not included) and is typically used in an intensive care setting to manage acute renal failure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009800625	GS1