Lumax™ TS Pro

GUDID 00888937013382

Lumax™ TS Pro Advanced Software

Coopersurgical, Inc.

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• Primary Device ID: 00888937013382
• NIH Device Record Key: b9454248-8973-4f9e-9b23-fc71933a886b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumax™ TS Pro
• Version Model Number: 23485
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	00888937013382 [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: 2016-09-23

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