EnSite™ NavX™ EN0010-100003331

GUDID 15414734210000

Surface Electrode Kit

ST. JUDE MEDICAL, INC.

Cardiac mapping system reference patch

• Primary Device ID: 15414734210000
• NIH Device Record Key: bf1d1eb2-22c5-4288-acd1-702bacb2ccc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnSite™ NavX™
• Version Model Number: EN0010-100003331
• Catalog Number: EN0010-100003331
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734210003 [Primary]
GS1	15414734210000 [Package]; Contains: 05414734210003; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083328

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: 5
• Public Version Date: 2019-07-09
• Device Publish Date: 2016-05-31

On-Brand Devices [EnSite™ NavX™]

• 15414734210000: Surface Electrode Kit
• 05414734210003: Surface Electrode Kit