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.

• 00763000612382 - CG Future™: 2025-05-20 BAND 638BL26 CG FUTURE ANULO 33L MDR
• 00763000612399 - CG Future™: 2025-05-20 BAND 638BL28 CG FUTURE ANULO 33L MDR
• 00763000612405 - CG Future™: 2025-05-20 BAND 638BL30 CG FUTURE ANULO 33L MDR
• 00763000612412 - CG Future™: 2025-05-20 BAND 638BL32 CG FUTURE ANULO 33L MDR
• 00763000612429 - CG Future™: 2025-05-20 BAND 638BL34 CG FUTURE ANULO 33L MDR
• 00763000612436 - CG Future™: 2025-05-20 BAND 638BL36 CG FUTURE ANULO 33L MDR
• 00763000612443 - CG Future™: 2025-05-20 BAND 638BL38 CG FUTURE ANULO 33L MDR
• 20199150016765 - NA: 2025-05-19 CUSTOM PACK BB10N39R1 10PK 1/2 RACE