3625

GUDID 05414734506380

ECG Cable External

ST. JUDE MEDICAL, INC.

Electrocardiographic lead set, reusable

• Primary Device ID: 05414734506380
• NIH Device Record Key: 380dd7b7-262c-44c5-8d54-9f1ac46fbbb7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3625
• Catalog Number: 3625
• Company DUNS: 790268031
• Company Name: ST. JUDE MEDICAL, 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: true
• Serial Number: false
• Manufacturing Date: true
• 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(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734506380 [Primary]

FDA Product Code

• NIK: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

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: 2025-12-30
• Device Publish Date: 2025-12-22

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05414734506380 - NA: 2025-12-30ECG Cable External
• 05414734506380 - NA: 2025-12-30 ECG Cable External
• 05415067052926 - Amplatzer Piccolo™: 2025-12-30 Delivery System
• 05415067054883 - EnSite™: 2025-12-29 X EP System Software Upgrade
• 05415067053435 - EnSite™: 2025-12-25 X EP System Software Upgrade
• 05415067053503 - EnSite™: 2025-12-25 X EP System Display Workstation
• 05415067053510 - EnSite™: 2025-12-25 X EP System Display Workstation
• 05415067054968 - EnSite™: 2025-12-25 X EP System
• 05415067054975 - EnSite™: 2025-12-25 X EP System