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.

• 20763000994185 - NA: 2025-02-07 CUSTOM PACK BB8Q17R2 2PK 1/4 X 1/4
• 20763000994246 - NA: 2025-02-07 CUSTOM PACK BB12L75R1 4PK OVP MYO
• 00763000994259 - NA: 2025-02-07 CUSTOM PACK BB11P48R4 ATTRNSFN SET
• 00763000994334 - NA: 2025-02-07 CUSTOM PACK BB6W69R18 ADULT PACK
• 20763000994352 - NA: 2025-02-07 CUSTOM PACK BB3P82R6 10PK VRV LINE
• 00763000994365 - NA: 2025-02-07 CUSTOM PACK BB9R12R17 FUSION PK
• 00763000994464 - NA: 2025-02-07 CUSTOM PACK BB12M85R 1/4 X 3/8
• 00763000994471 - NA: 2025-02-07 CUSTOM PACK BB10V22R9 TAVR PACK