Lumax

GUDID 50888937013493

Lumax™ TS Pro • EMG Electrodes

Coopersurgical, Inc.

Urodynamic measurement system

• Primary Device ID: 50888937013493
• NIH Device Record Key: fc8a5e72-9f3c-4304-bad3-a59631a4672d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumax
• Version Model Number: 53397
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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	50888937013493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953734

FDA Product Code

• FEN: Device, Cystometric, Hydraulic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Lumax]

• 60888937013452: Lumax™ TS Pro • EMG Software Upgrade Kit
• 50888937013493: Lumax™ TS Pro • EMG Electrodes