GUDID 00643169725126

EPG 5392 MKT USA MOLDED CASE

MEDTRONIC, INC.

External pacemaker, epicardial pacing External pacemaker, epicardial pacing

• Primary Device ID: 00643169725126
• NIH Device Record Key: 71a64009-624f-4c1c-b002-043242e4c73d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5392
• 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 Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169725126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162550

FDA Product Code

• DTE: PULSE-GENERATOR, PACEMAKER, EXTERNAL

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: 2018-10-05
• Device Publish Date: 2017-01-29

Devices Manufactured by MEDTRONIC, INC.

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• 00763000950699 - NA: 2024-05-07 CUSTOM PACK 5D56R9 NEURO FLOWS
• 00763000841591 - Cardioblate™ Gemini™-s: 2024-05-06 CARDIOBLATE GEMINI-S 49260 EN
• 00763000949341 - NA: 2024-05-06 CUSTOM PACK BB12A73R5 AV LOOP
• 20763000949369 - NA: 2024-05-06 CUSTOM PACK BB12F71R2 4PK LOYOLA CPG
• 00763000949372 - NA: 2024-05-06 CUSTOM PACK BB11L23R8 UTMC SUPP PK
• 20763000950105 - NA: 2024-05-06 CUSTOM PACK BB12G65R 5PK TAPER
• 00763000950118 - NA: 2024-05-06 CUSTOM PACK CB3Z71R24 PRIMARY