Glean GUS-1000-M

GUDID 00860009800601

Glean Sensor with Male Insertion Tool 5 Pack

Bright Uro, Inc

Urodynamic manometric catheter, electronic, single-use

• Primary Device ID: 00860009800601
• NIH Device Record Key: 707a1743-d8b1-4cd6-b3b5-410974a5165b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glean
• Version Model Number: GUS-1000-M
• Catalog Number: GUS-1000-M
• Company DUNS: 117955543
• Company Name: Bright Uro, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009800601 [Primary]

FDA Product Code

• EXQ: Cystometer, Electrical Recording

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-01
• Device Publish Date: 2025-09-23

On-Brand Devices [Glean]

• 00860009800656: Glean Sensor with Female Insertion Tool
• 00860009800649: Glean Sensor with Male Insertion Tool
• 00860009800632: Glean Uroflowmeter Charging Puck
• 00860009800625: Glean Uroflowmeter
• 00860009800601: Glean Sensor with Male Insertion Tool 5 Pack
• 00086000980061: Glean Sensor with Female Insertion Tool 5 Pack