Lumax™ TS Pro

GUDID 60888937013469

Lumax™ TS Pro Fiberoptic Cystometry System Sales Demo Unit

Coopersurgical, Inc.

Urodynamic measurement system

• Primary Device ID: 60888937013469
• NIH Device Record Key: 02dd0107-a35a-4aa4-8c63-4e3e154a77b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumax™ TS Pro
• Version Model Number: TSBAS-SRD
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	60888937013469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953734

FDA Product Code

• FEM: Accessories, Photographic, For Endoscope (Exclude Light Sources)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Lumax™ TS Pro ]

• 60888937013469: Lumax™ TS Pro Fiberoptic Cystometry System Sales Demo Unit
• 60888937013360: Lumax™ TS Pro Fiberoptic Cystometry System
• 60888937013339: Lumax™ TS Pro • EMG Module
• 00888937013382: Lumax™ TS Pro Advanced Software