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.

• 00199150021055 - NA: 2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT
• 00199150021062 - NA: 2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8
• 00199150021079 - NA: 2025-06-06 CUSTOM PACK BB7C59R10 E C L S
• 20199150021110 - NA: 2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E
• 20199150021134 - NA: 2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL
• 00199150021147 - NA: 2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK
• 20199150021165 - NA: 2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK
• 20199150021653 - NA: 2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE