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
• Email: 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.

• 00199150006045 - N/A: 2026-02-10 COMM HANDSET KIT TH90D01 DBS EMANUAL US
• 00199150068302 - NA: 2026-02-10 CUSTOM PACK BB12M12R7 HLO CPB
• 20199150068351 - NA: 2026-02-10 CUSTOM PACK 12C75R1 20PK ACC BIDMC-PCK
• 20199150068382 - NA: 2026-02-10 CUSTOM PACK BB12C41R9 10PK ACC LNG PK
• 00199150068869 - NA: 2026-02-10 CUSTOM PACK BB7V82R30 HLO L ADULT
• 20199150068900 - NA: 2026-02-10 CUSTOM PACK BB12T59R 2PK ACC STOPCOCK P
• 00199150068913 - NA: 2026-02-10 CUSTOM PACK BB11B96R6 HLO HEARTPACK
• 00199150068968 - NA: 2026-02-10 CUSTOM PACK BB8R57R10 AVL AV1/2X