VARIPULSE™ Bi-Directional Catheter D141201

GUDID 10846835025460

8.5 FR VARIPULSE™ Bi-Directional Catheter

Biosense Webster Inc

Cardiac irreversible electroporation system catheter

• Primary Device ID: 10846835025460
• NIH Device Record Key: 6d85d7a0-1566-4fc3-bdf7-f93b9dc6d1f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIPULSE™ Bi-Directional Catheter
• Version Model Number: D141201
• Catalog Number: D141201
• Company DUNS: 020163218
• Company Name: Biosense Webster Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835025460 [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: true

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: 2024-12-19 TRUPULSE Generator
• 10846835025460 - VARIPULSE™ Bi-Directional Catheter: 2024-12-198.5 FR VARIPULSE™ Bi-Directional Catheter
• 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