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
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 |
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.
| 20199150021677 - NA | 2025-06-16 CUSTOM PACK BB9H02R8 4PK 1/4A 3/8V |
| 00199150021680 - NA | 2025-06-16 CUSTOM PACK BB10T89R3 3/8 ECC |
| 00199150021697 - NA | 2025-06-16 CUSTOM PACK BB1B37R38 E WO R |
| 20199150021714 - NA | 2025-06-16 CUSTOM PACK BB11H35R5 5PK SUPP PCK |
| 00199150022519 - NA | 2025-06-16 CUSTOM PACK BB11R06R3 SUPP 1/4 PK |
| 00199150022526 - NA | 2025-06-16 CUSTOM PACK BB11N34R9 VVL |
| 00199150022533 - NA | 2025-06-16 CUSTOM PACK BB5W59R5 LEVITRON |
| 00199150023721 - NA | 2025-06-16 CUSTOM PACK BB9F75R9 E SUPPORT |
Trademark Results [Aurora EV-ICD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AURORA EV-ICD 97394547 not registered Live/Pending |
Medtronic, Inc. 2022-05-04 |
 AURORA EV-ICD 88690825 not registered Live/Pending |
Medtronic Inc. 2019-11-13 |
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