T-DOC 5Fr Air-Charged Abdominal Sensor Catheter

GUDID 20627825014841

T-DOC 5Fr Air-Charged Abdominal Sensor Catheter

Laborie Medical Technologies Corp.

Urodynamic manometric catheter, electronic, single-use

• Primary Device ID: 20627825014841
• NIH Device Record Key: a3087454-bbc2-416f-8e87-a4771ef72053
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-DOC 5Fr Air-Charged Abdominal Sensor Catheter
• Version Model Number: CAT575
• 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	10627825014844 [Primary]
GS1	20627825014841 [Package]; Contains: 10627825014844; Package: [10 Units]; In Commercial Distribution
GS1	30627825014848 [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

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• 10627825013533 - e•Sense 7Fr Single Sensor Coudé Bladder Catheter: 2024-12-20 e•Sense 7Fr Single Sensor Coudé Bladder Catheter
• 10627825013540 - e•Sense 7Fr Dual Sensor Urethral Catheter: 2024-12-20 e•Sense 7Fr Dual Sensor Urethral Catheter
• 00627825013550 - e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter: 2024-12-20 e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter