Reveal LINQ™

GUDID 00643169476998

MON LNQ11 LINQ USA NEW PA

MEDTRONIC, INC.

Implantable cardiac monitor

• Primary Device ID: 00643169476998
• NIH Device Record Key: a1664d25-6f91-4476-8bc8-6f0fcb27754b
• Commercial Distribution Discontinuation: 2018-06-21
• Commercial Distribution Status: Not 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169476998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150117

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: 2015-06-15

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