TRUPULSE™ Generator D141702

GUDID 10846835025248

TRUPULSE Generator

Biosense Webster Inc

Cardiac irreversible electroporation system generator

• Primary Device ID: 10846835025248
• NIH Device Record Key: 3d4560c5-e22a-44cf-b32f-0dc5027f46ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUPULSE™ Generator
• Version Model Number: D141702
• Catalog Number: D141702
• Company DUNS: 020163218
• Company Name: Biosense Webster Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835025248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240006

FDA Product Code

• QZI: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

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: 2024-12-19
• Device Publish Date: 2024-12-11

Devices Manufactured by Biosense Webster Inc

• 10846835010121 - Sterile Interface Cable: 2024-12-19 Cath to Generator CBL Sterile
• 10846835025248 - TRUPULSE™ Generator: 2024-12-19TRUPULSE Generator
• 10846835025248 - TRUPULSE™ Generator: 2024-12-19 TRUPULSE Generator
• 10846835025460 - VARIPULSE™ Bi-Directional Catheter: 2024-12-19 8.5 FR VARIPULSE™ Bi-Directional Catheter
• 10846835022780 - SOUNDSTAR CRYSTAL Ultrasound Catheter: 2024-07-04 SOUNDSTAR CRYSTAL Ultrasound Catheter
• 10846835016796 - TX eco EXT Cable: 2023-10-12 TX eco EXT Cable
• 10846835025811 - OPTRELL Mapping Catheter with TRUEref Technology: 2023-10-12 OPTRELL-36 F-J Curve
• 10846835025828 - OPTRELL Mapping Catheter with TRUEref Technology: 2023-10-12 OPTRELL-36 D-F Curve
• 10846835017427 - TX eco Cable: 2023-07-31 TX eco Cable Kit