NXT Pro Urodynamics System

GUDID 00627825011617

Laborie Medical Technologies Canada ULC

Urodynamic measurement system

• Primary Device ID: 00627825011617
• NIH Device Record Key: 653ecb8b-d357-43bb-b620-816662e1ada0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NXT Pro Urodynamics System
• Version Model Number: NXT2700
• Company DUNS: 203383526
• Company Name: Laborie Medical Technologies Canada ULC
• 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	00627825011617 [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: 2019-01-28
• Device Publish Date: 2018-12-27

Devices Manufactured by Laborie Medical Technologies Canada ULC

• 30627825007024 - Extension Set 2: 2022-07-04
• 20627825007294 - Extension Line, 60 cm: 2022-07-04
• 20627825007317 - Extension Line, 1500mm: 2022-07-04
• 20627825007324 - Extension Line, 15cm: 2022-07-04
• 20627825007348 - Extension Line, 150cm Blue: 2022-07-04
• 30627825007352 - Extension Line, 150cm Yellow: 2022-07-04
• 20627825007034 - Extension Set 3: 2022-07-04
• 30627825007307 - Extension Line, 90 cm: 2022-07-04