Affera™ Mapping System

GUDID 00763000871956

MAPPING SYSTEM AFR-00003 US

MEDTRONIC, INC.

Cardiac mapping system

• Primary Device ID: 00763000871956
• NIH Device Record Key: 12c2768f-15ff-4334-94bc-928a6d488870
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affera™ Mapping System
• Version Model Number: AFR-00003
• 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

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
• 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
• 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
• 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	00763000871956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233943

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: 2024-10-29
• Device Publish Date: 2024-10-21

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• 00763000582906 - Valve Handle 7420: 2025-03-03 HANDLE 7420 VLV HNDLE 234MM CEM GLOBAL
• 00763000911089 - NA: 2025-03-03 FOOT SWITCH NITRONFS GLOBAL
• 20763000954363 - N/A: 2025-03-03 PATCH AFR-00007 LOCATION REF 4PK US
• 20763000999197 - NA: 2025-03-03 CUSTOM PACK BB2N27R2 5PK CARDIO LN
• 20763000999753 - NA: 2025-03-03 CUSTOM PACK 12M79R 10PK TTS
• 20763000999210 - NA: 2025-02-28 CUSTOM PACK BB12D77R2 5PK HEAD PACK
• 20763000999234 - NA: 2025-02-28 CUSTOM PACK BB12D89R1 5PK HEAD ACC PACK