MEDTRONIC CARELINK® MONITOR

GUDID 00643169334717

MON 2490C15 CL 60601 3 ED LCM USA RFB

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use

• Primary Device ID: 00643169334717
• NIH Device Record Key: fb65b599-0677-4db7-b161-0858803899cd
• Commercial Distribution Discontinuation: 2019-01-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MEDTRONIC CARELINK® MONITOR
• Version Model Number: 2490C15
• 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: 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 Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169334717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890003

FDA Product Code

• NVZ: Pulse generator, permanent, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2014-09-23

On-Brand Devices [MEDTRONIC CARELINK® MONITOR]

• 00643169690943: MON 2490C17 CARELINK C17 VISIA CRTD USA
• 00643169376823: MON 2490C16 USA C16 HPMRI
• 00643169341050: MON 2490C15 CL 60601 3 ED HCM USA RFB
• 00643169334717: MON 2490C15 CL 60601 3 ED LCM USA RFB
• 00643169191815: MON 2490C15 USA C15 60601