Reveal LINQ™ Mobile Manager

GUDID 00643169545519

SW MSW001 LINQ MOBILE MANAGER USA

MEDTRONIC, INC.

Implantable cardiac device management application software

• Primary Device ID: 00643169545519
• NIH Device Record Key: ca839580-c507-4cb1-94a2-7165c56294c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reveal LINQ™ Mobile Manager
• Version Model Number: MSW001
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169545519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150614

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

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: 2015-11-11

On-Brand Devices [Reveal LINQ™ Mobile Manager]

• 00643169636651: SW MSW002 LINQ PROGRAMMER iOS APP
• 00643169545519: SW MSW001 LINQ MOBILE MANAGER USA