GUDID 00643169723160

EPG 53401 MKT US

MEDTRONIC, INC.

External pacemaker, epicardial pacing

• Primary Device ID: 00643169723160
• NIH Device Record Key: 2fe327e1-6611-4b10-a561-28a32b055287
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 53401
• 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

• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169723160 [Primary]

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: 6
• Public Version Date: 2018-10-15
• Device Publish Date: 2017-03-12

Devices Manufactured by MEDTRONIC, INC.

• 20763000980096 - NA: 2025-08-25 IMPEDANCE PATCH AFR-00015
• 20763000980119 - NA: 2025-08-25 MAGNETIC PATCH AFR-00021
• 00199150039371 - NA: 2025-08-22 CUSTOM PACK BB11U72R1 P/T
• 00199150040872 - NA: 2025-08-22 CUSTOM PACK BB4K95R22 HLO PERFNPLEG
• 00199150041145 - NA: 2025-08-22 CUSTOM PACK BB12Q87R1 HLN VAMC NASH
• 00199150041978 - NA: 2025-08-22 CUSTOM PACK BB10F40R2 ACCESORY
• 00199150041299 - NA: 2025-08-19 CUSTOM PACK BB8E60R12 EVL PED E
• 20199150041118 - NA: 2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE