CareLink SmartSync™ Azure Astra Application

GUDID 00763000002039

SW D00U003 SS AZURE ASTRA

MEDTRONIC, INC.

Implantable cardiac device management application software

• Primary Device ID: 00763000002039
• NIH Device Record Key: 7797dacb-23d2-44fe-989a-2d437c3d9e65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareLink SmartSync™ Azure Astra Application
• Version Model Number: D00U003
• 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	00763000002039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980035

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: 2
• Public Version Date: 2019-07-02
• Device Publish Date: 2019-04-06

Devices Manufactured by MEDTRONIC, INC.

• 00199150033966 - NA: 2025-08-04 CUSTOM PACK BB10N41R3 SUPPORT SM
• 00199150034017 - NA: 2025-08-04 CUSTOM PACK BB9P05R5 316/14
• 20199150034172 - NA: 2025-08-04 CUSTOM PACK BB12Q65R 10PK UC BAL TUB14-8
• 00199150034239 - NA: 2025-08-04 CUSTOM PACK 12Q76R VAVD PK
• 00199150034345 - NA: 2025-08-04 CUSTOM PACK BB11R40R8 TRANS PORT
• 00199150034352 - NA: 2025-08-04 CUSTOM PACK BB9P03R5 14/38 AV
• 00199150034369 - NA: 2025-08-04 CUSTOM PACK BB9Q43R4 38/12 AV
• 20199150034394 - NA: 2025-08-04 CUSTOM PACK BB12N77R1 4PK 3/8 STRAIGHT