PIM NXT for eSense

GUDID 08720648846069

Laborie Medical Technologies Corp.

Urodynamic measurement system

• Primary Device ID: 08720648846069
• NIH Device Record Key: a0fe2190-37f4-414b-9757-9dbd300decf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIM NXT for eSense
• Version Model Number: PIX7000
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	08720648846069 [Primary]

FDA Product Code

• FEN: Device, Cystometric, Hydraulic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-03
• Device Publish Date: 2025-02-21

Devices Manufactured by Laborie Medical Technologies Corp.

• 08720648846069 - PIM NXT for eSense: 2025-03-03
• 08720648846069 - PIM NXT for eSense: 2025-03-03
• 00627825013529 - e•Sense 7Fr Single Sensor Bladder Catheter: 2024-12-20 e•Sense 7Fr Single Sensor Bladder Catheter
• 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
• 00627825013567 - e•Sense 7Fr Abdominal Catheter: 2024-12-20 e•Sense 7Fr Abdominal Catheter
• 20627825014841 - T-DOC 5Fr Air-Charged Abdominal Sensor Catheter: 2024-12-20 T-DOC 5Fr Air-Charged Abdominal Sensor Catheter
• 20627825014858 - T-DOC 5Fr Air-Charged Single Sensor Catheter: 2024-12-20 T-DOC 5Fr Air-Charged Single Sensor Catheter