Livewire™ 402208

GUDID 05414734200295

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Cardiac mapping/radio-frequency ablation catheter, single-use

• Primary Device ID: 05414734200295
• NIH Device Record Key: 1b7e16b7-c9c0-4ae2-bd30-279df0aa1045
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Livewire™
• Version Model Number: TC XLS™
• Catalog Number: 402208
• Company DUNS: 040960379
• Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
• 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(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep out of sunlight. Keep away from Heat and Radiation.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734200295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960016

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-28
• Device Publish Date: 2014-09-23

On-Brand Devices [Livewire™]

• 05414734202817: 402032
• 05414734202749: 401991
• 05414734202732: 401990
• 05414734202695: 401941
• 05414734202688: 401940
• 05414734202671: 401939
• 05414734202664: 401938
• 05414734202619: CSL™
• 05414734202602: 401923
• 05414734202589: 401917
• 05414734202572: 401915
• 05414734202510: Cannulator™
• 05414734202428: 401655
• 05414734202404: 401653
• 05414734202398: 401652
• 05414734202251: 401582
• 05414734202244: 401581
• 05414734202237: 401580
• 05414734202183: 401575
• 05414734200325: TC XLS™
• 05414734200318: TC XLS™
• 05414734200301: TC XLS™
• 05414734200295: TC XLS™
• 05414734200288: TC XLS™
• 05414734200271: TC XLS™
• 05414734200257: TC XLS™
• 05414734200240: TC XLS™
• 05414734200233: TC XLS™
• 05414734200226: TC XLS™