Reveal LINQ™

GUDID 00643169845893

MON LNQ11 REVEAL LINQ USA FW2.0

MEDTRONIC, INC.

Implantable cardiac monitor

• Primary Device ID: 00643169845893
• NIH Device Record Key: affc74f5-aa87-4c48-ab15-8c5e4a65a8e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reveal LINQ™
• Version Model Number: LNQ11
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169845893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162855

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-27
• Device Publish Date: 2020-01-19

On-Brand Devices [Reveal LINQ™]

• 00643169845749: MON LNQ11 REVEAL LINQ USA FW2.0
• 00643169476998: MON LNQ11 LINQ USA NEW PA
• 00643169845893: MON LNQ11 REVEAL LINQ USA FW2.0
• 00763000562632: MON LNQ11 REVEAL LINQ USA
• 00763000562625: MON LNQ11 REVEAL LINQ USA