Reveal LINQ™, Reveal®

GUDID 00643169547940

MON LNQ11 LINQ USA NEW PST

MEDTRONIC, INC.

Implantable cardiac monitor Implantable cardiac monitor

• Primary Device ID: 00643169547940
• NIH Device Record Key: 05130bb4-7be2-4bb5-9b96-efee5ff04868
• Commercial Distribution Discontinuation: 2018-09-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Reveal LINQ™, Reveal®
• 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
• 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
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169547940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132649

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-09
• Device Publish Date: 2015-06-10

On-Brand Devices [Reveal LINQ™, Reveal®]

• 00643169547940: MON LNQ11 LINQ USA NEW PST
• 00643169323575: MON LNQ11 REVEAL LINQ US MR