ENSITE-ADAS-01

GUDID 05415067051233

ADAS 3D Base License Software License

ST. JUDE MEDICAL, INC.

Cardiac mapping system application software

• Primary Device ID: 05415067051233
• NIH Device Record Key: 1db400c5-210f-4eac-9b17-3b1339e4559f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ENSITE-ADAS-01
• Catalog Number: ENSITE-ADAS-01
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067051233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242016

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: 2025-08-25
• Device Publish Date: 2025-08-15

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067053114 - EnSite™: 2025-09-15 X EP System Software Upgrade
• 05415067053343 - EnSite™: 2025-09-12 X EP System OTA Certificate Software License
• 05415067001474 - WorkMate™ Unity™: 2025-09-08 Module HL-7 Module
• 05415067001481 - WorkMate™ Unity™: 2025-09-08 Module DICOM Module
• 05415067051226 - EnSite™: 2025-08-25 X EP System Display Workstation
• 05415067051233 - NA: 2025-08-25ADAS 3D Base License Software License
• 05415067051233 - NA: 2025-08-25 ADAS 3D Base License Software License
• 05415067051257 - EnSite™: 2025-08-25 X EP System Display Workstation
• 05415067051264 - NA: 2025-08-25 ADAS 3D LA License Software License