PACEART® SYSTEM ECG MODULE

GUDID 00613994546180

ECG P127TUV PACEART SYSTEM FW 1.09 GLBL

MEDTRONIC, INC.

Patient health record information system application software

• Primary Device ID: 00613994546180
• NIH Device Record Key: 8ffcc8e3-82d9-48fe-81ac-2b5e55cb55d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACEART® SYSTEM ECG MODULE
• Version Model Number: P127TUV
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994546180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024278

FDA Product Code

• DPS: Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-04
• Device Publish Date: 2019-10-25

Devices Manufactured by MEDTRONIC, INC.

• 00199150037995 - NA: 2025-08-15 CUSTOM PACK BB12P51R4 EVL ORS PK
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• 00199150039210 - NA: 2025-08-15 CUSTOM PACK BB11U75R5 GOLD PACK