GUDID 20613994300083

COVER 5441 DISPOSABLE EPG 3PK 16L

MEDTRONIC, INC.

External pacemaker cover

• Primary Device ID: 20613994300083
• NIH Device Record Key: 4faa4f5e-866f-4cb3-953a-a162cb71eeaa
• Commercial Distribution Discontinuation: 2016-01-04
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 5441
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 3
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994300089 [Unit of Use]
GS1	20613994300083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P820003

FDA Product Code

• LWP: Implantable pulse generator, pacemaker (non-CRT)

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

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