LOCALISA®

GUDID 20643169006878

ELECTRODE 9670590 5BX LOCALISA

MEDTRONIC, INC.

Cardiac mapping system reference patch

• Primary Device ID: 20643169006878
• NIH Device Record Key: f4d0b375-3710-43fa-bdca-d94405d713fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOCALISA®
• Version Model Number: 9670590
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169006874 [Primary]
GS1	20643169006878 [Package]; Contains: 00643169006874; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002869

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-30

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