CARELINK® MONITOR

GUDID 00643169102101

MON 2490H9 CARELINK EXPRESS USA RFB

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use

• Primary Device ID: 00643169102101
• NIH Device Record Key: ea2bd91e-00df-4040-bef8-6328b8604629
• Commercial Distribution Discontinuation: 2019-01-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CARELINK® MONITOR
• Version Model Number: 2490H9
• 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 Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169102101 [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: 2019-02-18
• Device Publish Date: 2014-09-23

On-Brand Devices [CARELINK® MONITOR]

• 00613994910387: MON 2490H7 REFURB ADAPTA MCI IDC UL
• 00613994381071: MONITOR 2490J5 CARELINK US MCI IDC UL
• 00643169102101: MON 2490H9 CARELINK EXPRESS USA RFB
• 00643169102095: MON 2490G21 CARELINK MR4 USA RFB
• 00643169459885: MON 2490G24 CARELINK MR6 USA
• 00643169402904: MON 2490G23 CARELINK MR5 USA
• 00643169341074: MON 2490H10 60601 3RD ED USA RFB
• 00643169341067: MON 2490G23 CARELINK MR5 USA RFB
• 00643169312913: MON 2490H10 CARELINK 60601 3ED USA