Advisor™ H702520

GUDID 05415067031471

Software Installation

ST. JUDE MEDICAL, INC.

Cardiac mapping system application software Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable

• Primary Device ID: 05415067031471
• NIH Device Record Key: 7d039c0a-b875-400e-b74f-69a4acf95799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advisor™
• Version Model Number: VL Mapping Catheter, Sensor Enabled™
• Catalog Number: H702520
• 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: false
• Lot Batch: true
• Serial Number: false
• 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(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 Identifiers

Device Issuing Agency	Device ID
GS1	05415067031471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183128

FDA Product Code

• DQK: Computer, diagnostic, programmable

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: 2019-10-01
• Device Publish Date: 2019-09-23

On-Brand Devices [Advisor™]

• 05415067025975: Circular Mapping Catheter
• 05415067025968: Circular Mapping Catheter
• 05415067024817: Circular Mapping Catheter
• 05415067024800: Circular Mapping Catheter
• 05415067031471: Software Installation
• 05415067030092: Catheter Catalog Installation