HexaPulse™ PF Generator

GUDID 00763000871925

GENERATOR AFR-00008 HEXAPULSE PF US

MEDTRONIC, INC.

Cardiac irreversible electroporation system generator

• Primary Device ID: 00763000871925
• NIH Device Record Key: 824ee69a-e8a4-46ab-ac2a-68f770c2d103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HexaPulse™ PF Generator
• Version Model Number: AFR-00008
• 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: false
• Serial Number: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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	00763000871925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240013

FDA Product Code

• OAE: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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: 2024-11-12
• Device Publish Date: 2024-11-04

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• 00763000973391 - Sphere-9™ Catheter: 2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR
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• 00763000986773 - NA: 2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK
• 20763000986814 - NA: 2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES