OmniaSecure™ MRI SureScan™

GUDID 00763000643539

LEAD 3930M64 US MKT 64 CM DF4 MR EN

MEDTRONIC, INC.

Endocardial defibrillation lead

• Primary Device ID: 00763000643539
• NIH Device Record Key: 5a5fd0c4-c993-473f-b575-30e304810bdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniaSecure™ MRI SureScan™
• Version Model Number: 3930M64
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 64 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000643539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240036

FDA Product Code

• NVY: Permanent defibrillator electrodes

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [OmniaSecure™ MRI SureScan™]

• 00763000643539: LEAD 3930M64 US MKT 64 CM DF4 MR EN
• 00763000643478: LEAD 3930M84 US MKT 84 CM DF4 MR EN
• 00763000643454: LEAD 3930M79 US MKT 79 CM DF4 MR EN
• 00763000643430: LEAD 3930M74 US MKT 74 CM DF4 MR EN
• 00763000643416: LEAD 3930M69 US MKT 69 CM DF4 MR EN