CareLink SmartSync™ Percepta Serena Solara Application
GUDID 00763000002046
SW D00U004 SS PERCEPTA SERENA SOLERA
MEDTRONIC, INC.
Implantable cardiac device management application software| Primary Device ID | 00763000002046 |
| NIH Device Record Key | 17e7aa59-ea67-4bed-80c4-86ce47eaf82f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareLink SmartSync™ Percepta Serena Solara Application |
| Version Model Number | D00U004 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | 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 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000002046 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P010015
FDA Product Code
| OSR | Pacemaker/icd/crt non-implanted components |
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 | 2019-07-22 |
| Device Publish Date | 2019-07-13 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000643416 - OmniaSecure™ MRI SureScan™ | 2025-12-29 LEAD 3930M69 US MKT 69 CM DF4 MR EN |
| 00763000643430 - OmniaSecure™ MRI SureScan™ | 2025-12-29 LEAD 3930M74 US MKT 74 CM DF4 MR EN |
| 00763000643454 - OmniaSecure™ MRI SureScan™ | 2025-12-29 LEAD 3930M79 US MKT 79 CM DF4 MR EN |
| 00763000643478 - OmniaSecure™ MRI SureScan™ | 2025-12-29 LEAD 3930M84 US MKT 84 CM DF4 MR EN |
| 00763000643539 - OmniaSecure™ MRI SureScan™ | 2025-12-29 LEAD 3930M64 US MKT 64 CM DF4 MR EN |
| 00199150064052 - NA | 2025-12-23 CUSTOM PACK BB1B62R41 HLN CHR LNNT |
| 00199150064847 - NA | 2025-12-22 CUSTOM PACK BB12P57R3 HLO IOM FUS M |
| 00199150064861 - NA | 2025-12-22 CUSTOM PACK BB12S99R1 EVL NEONAT |
Trademark Results [CareLink SmartSync]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARELINK SMARTSYNC 86909270 not registered Live/Pending |
Medtronic, Inc. 2016-02-16 |
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