LINQ II™

GUDID 00763000162191

TOOL KIT LNQ22TK LINQ II USA

MEDTRONIC, INC.

Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor

• Primary Device ID: 00763000162191
• NIH Device Record Key: b4d08f55-c71f-4feb-8882-afcac3c0018a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINQ II™
• Version Model Number: LNQ22TK
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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 -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000162191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200795

FDA Product Code

• MXD: Recorder, event, implantable cardiac, (with arrhythmia detection)

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: 2020-07-27
• Device Publish Date: 2020-07-18

On-Brand Devices [LINQ II™]

• 00763000162191: TOOL KIT LNQ22TK LINQ II USA
• 00763000060374: ICM LNQ22 LINQ II USA
• 00763000554002: ICM LNQ22 LINQ II USA
• 00763000613747: ICM LNQ22 LINQ II PRIME US