CareLink Express™ Mobile System

GUDID 00643169545526

SW 31301 CARELINK EXPRESS MOBILE USA

MEDTRONIC, INC.

Implantable cardiac device management application software

• Primary Device ID: 00643169545526
• NIH Device Record Key: e3b3a4cc-83e9-471a-b631-ecae58559379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareLink Express™ Mobile System
• Version Model Number: 31301
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169545526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890003

FDA Product Code

• OSR: Pacemaker/icd/crt non-implanted components

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-25

On-Brand Devices [CareLink Express™ Mobile System]

• 00643169636668: SW 31302 CARELINK EXPRESS MOBILE IOS USA
• 00643169545526: SW 31301 CARELINK EXPRESS MOBILE USA