Lumax

GUDID 60888937013452

Lumax™ TS Pro • EMG Software Upgrade Kit

Coopersurgical, Inc.

Urodynamic measurement system

• Primary Device ID: 60888937013452
• NIH Device Record Key: 3cb3046a-c1d0-41ac-9ba0-f6b7598d89eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumax
• Version Model Number: 53366
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	60888937013452 [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: 2016-08-31

On-Brand Devices [Lumax]

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