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.

• 00763000960308 - NA: 2024-07-09 CUSTOM PACK BB12C30R7 NPR IMC
• 00763000960407 - NA: 2024-07-09 CUSTOM PACK BB12G16R3 UCHICAGO CPB
• 00763000228699 - NA: 2024-07-08 KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ
• 00763000957193 - NA: 2024-07-08 CUSTOM PACK BB7M46R25 SCV ADLT
• 20763000960272 - NA: 2024-07-08 CUSTOM PACK 10R91R5 10PK LRTXBYPS
• 20763000960296 - NA: 2024-07-08 CUSTOM PACK SSBB12D06R4 4PK RESOXY BYPA
• 00763000879273 - Verify™: 2024-07-05 ENS 353101 VERIFY ISTM US EMANUAL
• 00763000879280 - Verify™: 2024-07-05 ENS 353101 VERIFY ISTM US REFURB EMAN