Urocap NXT

GUDID 00627825011723

Laborie Medical Technologies Canada ULC

Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system Urodynamic measurement system

• Primary Device ID: 00627825011723
• NIH Device Record Key: a6dfd7c0-deeb-4fe4-b365-df600a5ca61f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urocap NXT
• Version Model Number: UCX2001
• 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	00627825011723 [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: 2020-10-12
• Device Publish Date: 2020-10-02

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