CareLink SmartSync™ PSA Application

GUDID 00643169833753

SW D00U002 CARELINK SMARTSYNC PSA APP

MEDTRONIC, INC.

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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: 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.

• 00199150042005 - NA: 2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8
• 00199150042012 - NA: 2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM
• 00199150042029 - NA: 2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4
• 00199150042043 - NA: 2025-08-29 CUSTOM PACK BB9E98R16 EVL WCH PED
• 00199150042067 - NA: 2025-08-29 CUSTOM PACK BB7E31R31 EVL 1 EVT 1/4
• 00199150042739 - NA: 2025-08-29 CUSTOM PACK BB7V67R13 HLO PRESBY
• 00199150042746 - NA: 2025-08-29 CUSTOM PACK BB0C00R32 EVL 3/8SUPPT
• 00763000658960 - Profile 3D™: 2025-08-29 HANDLE 7686L ANNULOPLASTY2 MDR