EP-4™ H21913

GUDID 05414734219136

Cardiac Stimulator Keyboard

ST. JUDE MEDICAL, INC.

Cardiac electrophysiology stimulation system

• Primary Device ID: 05414734219136
• NIH Device Record Key: 3f54f8bd-67c1-4ba8-b387-f9828cfa3435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EP-4™
• Version Model Number: H21913
• Catalog Number: H21913
• Company DUNS: 149818952
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734219136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092913

FDA Product Code

• JOQ: Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)

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: 2025-09-19
• Device Publish Date: 2025-09-11

On-Brand Devices [EP-4™]

• 05414734219112: Touch Screen Computer
• 05414734208758: Cardiac Stimulator
• 05414734208741: Cardiac Stimulator
• 05414734030236: Cardiac Stimulator
• 05415067001627: Cardiac Stimulator Cardiac Stimulator Cable
• 05415067051837: Cardiac Stimulator Cardiac Stimulator Cable 15 ft
• 05415067051820: Cardiac Stimulator Cardiac Stimulator Cable 30 ft
• 05415067007889: Cardiac Stimulator Cardiac Stimulator Cable
• 05415067007872: Cardiac Stimulator Cardiac Stimulator Cable
• 05415067007865: Cardiac Stimulator Cardiac Stimulator Cable
• 05415067002709: Cardiac Stimulator Cardiac Stimulator Cable
• 05414734219136: Cardiac Stimulator Keyboard