EP-NurseMate™ H700097

GUDID 05415067000972

ST. JUDE MEDICAL, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 05415067000972
• NIH Device Record Key: 54057bcb-0b26-4acb-a848-97178fd25f0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EP-NurseMate™
• Version Model Number: H700097
• Catalog Number: H700097
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067000972 [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-NurseMate™]

• 05415067000972: H700097
• 05414734207782: Physio Module