Lumax TS Pro

GUDID 20888937011177

Fiberoptic Pressure Transducer Catheter: Bladder, 10 French

Coopersurgical, Inc.

Urodynamic manometric catheter, electronic, single-use

• Primary Device ID: 20888937011177
• NIH Device Record Key: ee0b36d0-4a53-44f1-bc39-cec27a835116
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumax TS Pro
• Version Model Number: 10307-010
• 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	00888937011173 [Primary]
GS1	20888937011177 [Package]; Contains: 00888937011173; Package: [10 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-13
• Device Publish Date: 2016-05-09

On-Brand Devices [Lumax TS Pro]

• 00888937014044: Lumax TS Pro Fiberoptic Transmission Cable Reusable • Length: 44" (112 cm)
• 20888937011177: Fiberoptic Pressure Transducer Catheter: Bladder, 10 French
• 20888937011160: Fiberoptic Pressure Transducer Catheter: Abdominal, 10 French
• 20888937011153: Fiberoptic Pressure Transducer Catheter: Bladder, 7 French