T-DOC 5Fr Air-Charged Single Sensor Catheter

GUDID 20627825014865

T-DOC 5Fr Air-Charged Single Sensor Catheter with stylet

Laborie Medical Technologies Corp.

Urodynamic manometric catheter, electronic, single-use

• Primary Device ID: 20627825014865
• NIH Device Record Key: bc6326bc-0ea7-47a8-8627-48bea467a19c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-DOC 5Fr Air-Charged Single Sensor Catheter
• Version Model Number: CAT595S
• Company DUNS: 117783313
• Company Name: Laborie Medical Technologies Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10627825014868 [Primary]
GS1	20627825014865 [Package]; Contains: 10627825014868; Package: [10 Units]; In Commercial Distribution
GS1	30627825014862 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• FEN: Device, Cystometric, Hydraulic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [T-DOC 5Fr Air-Charged Single Sensor Catheter]

• 20627825014865: T-DOC 5Fr Air-Charged Single Sensor Catheter with stylet
• 20627825014858: T-DOC 5Fr Air-Charged Single Sensor Catheter