EP-WorkMate™ H700096

GUDID 05415067000965

ST. JUDE MEDICAL, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 05415067000965
• NIH Device Record Key: e371497a-d046-4720-822c-d4601143dd55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EP-WorkMate™
• Version Model Number: Recording System
• Catalog Number: H700096
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067000965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092810

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-06

On-Brand Devices [EP-WorkMate™]

• 05415067003560: Software Upgrade Kit
• 05415067003553: Software Upgrade Kit
• 05415067003461: 09-0080-0000
• 05415067003126: 56 Channel SCU
• 05415067003119: 120 Channel SCU
• 05415067000965: Recording System
• 05415067000866: Software Upgrade Kit v.4.3.2
• 05414734219105: Recording System
• 05414734207546: Recording System