EP-4™ H21911

GUDID 05414734219112

Touch Screen Computer

ST. JUDE MEDICAL, INC.

Cardiac electrophysiology stimulation system

• Primary Device ID: 05414734219112
• NIH Device Record Key: d297abfd-d842-4e53-81fe-8c4369322498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EP-4™
• Version Model Number: H21911
• Catalog Number: H21911
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734219112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092913

FDA Product Code

• JOQ: GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-12
• Device Publish Date: 2016-04-22

On-Brand Devices [EP-4™]

• 05414734219112: Touch Screen Computer
• 05414734208758: Cardiac Stimulator
• 05414734208741: Cardiac Stimulator
• 05414734030236: Cardiac Stimulator