TactiFlex™ Sensor Enabled™ A-TFSE-DF

GUDID 05415067034571

Ablation Catheter

ST. JUDE MEDICAL, INC.

Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter Cardiac radio-frequency ablation system catheter

• Primary Device ID: 05415067034571
• NIH Device Record Key: 33fec2fe-5eec-467d-9dfc-e0182cddbd34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TactiFlex™ Sensor Enabled™
• Version Model Number: A-TFSE-DF
• Catalog Number: A-TFSE-DF
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Dimensions

• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French
• Length: 115 Centimeter
• Catheter Gauge: 8 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067034571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220013

FDA Product Code

• OAE: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [TactiFlex™ Sensor Enabled™]

• 05415067034694: Ablation Catheter
• 05415067034670: Ablation Catheter
• 05415067034656: Ablation Catheter
• 05415067034632: Ablation Catheter
• 05415067034618: Ablation Catheter
• 05415067034595: Ablation Catheter
• 05415067034571: Ablation Catheter
• 05415067034557: Ablation Catheter