MyCareLink Smart™

GUDID 00643169527539

MON 25000 MYCARELINK SMART US

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use

• Primary Device ID: 00643169527539
• NIH Device Record Key: ff87c0c3-cfb0-4aef-b89c-870340e03aac
• Commercial Distribution Discontinuation: 2019-01-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MyCareLink Smart™
• Version Model Number: 25000
• 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 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169527539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890003

FDA Product Code

• FMH: CONTAINER, SPECIMEN, STERILE

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: 2015-02-24

On-Brand Devices [MyCareLink Smart™]

• 00643169666320: MON 25000 MCL SMART 2.1 US
• 00643169569744: MON 25000 MYCARELINK SMART US
• 00643169527539: MON 25000 MYCARELINK SMART US
• 00763000305079: MON 25000 MCL SMART 2.1 USA