CareLink Encore™

GUDID 00613994909565

PROGR HEAD 26901 ENCORE

MEDTRONIC, INC.

Cardiac pulse generator programmer Cardiac pulse generator programmer

• Primary Device ID: 00613994909565
• NIH Device Record Key: d8cf737e-212d-4ac9-8c28-b4237b911f1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareLink Encore™
• Version Model Number: 26901
• 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994909565 [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: 2014-11-20

On-Brand Devices [CareLink Encore™]

• 00613994909688: PROGRAMMER 29901 CARELINK ENCORE US
• 00613994909565: PROGR HEAD 26901 ENCORE
• 00643169763548: PRGM 29901A ENCORE US EIFU
• 00643169369030: PROGRAMMER 29901 CARELINK ENCORE US