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.

• 00643169955653 - N'VISION®: 2024-10-14 SOFTWARE 8870AAV01 N'VISION US
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• 00763000978297 - NA: 2024-10-14 CUSTOM PACK BB11F30R2 ADULTRES
• 00763000978303 - NA: 2024-10-14 CUSTOM PACK 3Y90R11 NURSES
• 00763000978426 - NA: 2024-10-14 CUSTOM PACK BB11C01R9 CHILD PACK
• 00763000978549 - NA: 2024-10-14 CUSTOM PACK BB12F68R6 SPECIALTY CAR
• 00763000978648 - NA: 2024-10-14 CUSTOM PACK BB2G71R11 ST. AGNES PK
• 00763000979119 - NA: 2024-10-14 CUSTOM PACK BB8P50R4 SUPPORT