Affera™ Integrated Mapping System

GUDID 00763000998271

MAP SYS AFR-00016 IMPEDANCE US PLX

MEDTRONIC, INC.

Cardiac mapping system

• Primary Device ID: 00763000998271
• NIH Device Record Key: 170bea07-65ae-4d7d-a914-58b7833178a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affera™ Integrated Mapping System
• Version Model Number: AFR-00016
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000998271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243892

FDA Product Code

• DQK: Computer, diagnostic, programmable

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: 2025-09-01
• Device Publish Date: 2025-08-22

Devices Manufactured by MEDTRONIC, INC.

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• 20199150068238 - NA: 2026-02-02 CUSTOM PACK BB12S73R1 20PK ACC 3LF
• 20199150068290 - NA: 2026-02-02 CUSTOM PACK 12T24R 5PK ACC CARDIO
• 20199150068405 - NA: 2026-02-02 CUSTOM PACK BB12R56R3 4PK CPN DEL NI
• 00199150061679 - NA: 2026-01-29 CUSTOM PACK BB12S73R HLN 3LF
• 20613994654063 - DLP®: 2026-01-29 PCP SET 50011 5FR - 14GA 10PK 17L
• 00199150027521 - Cardioblate™: 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT