GUDID 20763000980119

MAGNETIC PATCH AFR-00021

MEDTRONIC, INC.

Cardiac mapping system reference patch

• Primary Device ID: 20763000980119
• NIH Device Record Key: b5c34bc3-f357-4b38-bd0c-24678f6dd94e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AFR-00021
• 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: true
• Device Combination Product: false
• Single Use: true
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000980115 [Primary]
GS1	20763000980119 [Package]; Contains: 00763000980115; Package: PK [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243435

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: 2025-08-25
• Device Publish Date: 2025-08-15

Devices Manufactured by MEDTRONIC, INC.

• 20763000980096 - NA: 2025-08-25 IMPEDANCE PATCH AFR-00015
• 20763000980119 - NA: 2025-08-25MAGNETIC PATCH AFR-00021
• 20763000980119 - NA: 2025-08-25 MAGNETIC PATCH AFR-00021
• 00199150039371 - NA: 2025-08-22 CUSTOM PACK BB11U72R1 P/T
• 00199150040872 - NA: 2025-08-22 CUSTOM PACK BB4K95R22 HLO PERFNPLEG
• 00199150041145 - NA: 2025-08-22 CUSTOM PACK BB12Q87R1 HLN VAMC NASH
• 00199150041978 - NA: 2025-08-22 CUSTOM PACK BB10F40R2 ACCESORY
• 00199150041299 - NA: 2025-08-19 CUSTOM PACK BB8E60R12 EVL PED E
• 20199150041118 - NA: 2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE