EnSite™ Fusion™ H702506

GUDID 05415067026224

Software Upgrade Kit, v.7.1

ST. JUDE MEDICAL, INC.

Cardiac mapping system application software

• Primary Device ID: 05415067026224
• NIH Device Record Key: b2d248b7-cc1c-4181-9800-aad93c2d1fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnSite™ Fusion™
• Version Model Number: H702506
• Catalog Number: H702506
• 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
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067026224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160187
• Premarket Notification: K201181

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-12-08

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067046734 - Ampere™: 2025-01-22 Generator
• 05415067046741 - Ampere™: 2025-01-22 Generator Kit
• 05415067046789 - Ampere™: 2025-01-22 Remote Control
• 05415067042934 - Regent™: 2025-01-20 Mechanical Heart Valve
• 05415067042958 - Regent™: 2025-01-20 Mechanical Heart Valve
• 05415067042972 - Masters Series™: 2025-01-20 HP Mechanical Heart Valve
• 05415067043016 - Masters Series™: 2025-01-20 Mechanical Heart Valve
• 05415067043030 - Masters Series™: 2025-01-20 Mechanical Heart Valve