CareLink SmartSync™ Azure Astra Application
GUDID 00763000002039
SW D00U003 SS AZURE ASTRA
MEDTRONIC, INC.
Implantable cardiac device management application software| Primary Device ID | 00763000002039 |
| NIH Device Record Key | 7797dacb-23d2-44fe-989a-2d437c3d9e65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareLink SmartSync™ Azure Astra Application |
| Version Model Number | D00U003 |
| 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 | 00763000002039 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P980035
FDA Product Code
| DTC | ANALYZER, PACEMAKER GENERATOR FUNCTION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-02 |
| Device Publish Date | 2019-04-06 |
Devices Manufactured by MEDTRONIC, INC.
| 20763000825380 - NA | 2024-11-20 CUSTOM PACK CB12B36R1 4PK DEL NIDO CPG |
| 20763000984193 - NA | 2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG |
| 20763000982946 - NA | 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD |
| 00763000984007 - NA | 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG |
| 00763000984021 - NA | 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE |
| 00763000984151 - NA | 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT |
| 00763000984168 - NA | 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS |
| 00763000984175 - NA | 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK |
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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