Aurora EV-ICD™ MRI SureScan™

GUDID 00763000368470

ICD-VR DVEA3E4 EV ICD EV4 US

MEDTRONIC, INC.

Single-chamber implantable defibrillator

• Primary Device ID: 00763000368470
• NIH Device Record Key: dd3893ab-34ff-48b3-9f02-19eb0c2870fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora EV-ICD™ MRI SureScan™
• Version Model Number: DVEA3E4
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000368470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P220012

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

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: 2023-11-10
• Device Publish Date: 2023-11-02

Devices Manufactured by MEDTRONIC, INC.

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