MEDTRONIC CARELINK EXPRESS™

GUDID 00643169107052

MON 2020B2 CARELINK USA MR4 MONITOR

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use

• Primary Device ID: 00643169107052
• NIH Device Record Key: 49c31ea4-9c63-4bbf-974b-70510730faeb
• Commercial Distribution Discontinuation: 2019-04-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MEDTRONIC CARELINK EXPRESS™
• Version Model Number: 2020B2
• 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
• 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	00643169107052 [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: 2019-05-07
• Device Publish Date: 2014-09-23

On-Brand Devices [MEDTRONIC CARELINK EXPRESS™]

• 00613994952431: MON 2020C1 CARELINK USA EXPRESS MONITOR
• 00613994952400: MON 2020B1 CARELINK USA EXPRESS MONITOR
• 00643169107052: MON 2020B2 CARELINK USA MR4 MONITOR
• 00643169312081: MON 2020C2 CARELINK 60601 3ED USA
• 00643169192058: MON 2020B3 CARELINK USA BW 60601