CareLink SmartSync™ PSA Application
GUDID 00643169833753
SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
Implantable cardiac device management application software Implantable cardiac device management application software| Primary Device ID | 00643169833753 |
| NIH Device Record Key | 32a9e825-7db7-4c24-8b27-215a89de45c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareLink SmartSync™ PSA Application |
| Version Model Number | D00U002 |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169833753 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163008
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 | 5 |
| Public Version Date | 2019-07-02 |
| Device Publish Date | 2017-05-25 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000944322 - NA | 2024-04-23 CUSTOM PACK HY4953R31 MEMB PK |
| 00763000944339 - NA | 2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK |
| 00763000944346 - NA | 2024-04-23 CUSTOM PACK BB12F35R5 A PACK |
| 00763000945558 - NA | 2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO |
| 00763000943844 - NA | 2024-04-12 CUSTOM PACK BB11J59R5 PEDS |
| 00763000943851 - NA | 2024-04-12 CUSTOM PACK BB12F35R3 A PACK |
| 00763000943868 - NA | 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT |
| 00763000943899 - NA | 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD |
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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