AptiVue™ 1014661

GUDID 05415067030108

Software Upgrade Kit

ST. JUDE MEDICAL, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 05415067030108
• NIH Device Record Key: a9945400-5c2f-43f6-badb-77203227a2a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AptiVue™
• Version Model Number: 1014661
• Catalog Number: 1014661
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067030108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183320

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2019-05-08
• Device Publish Date: 2019-04-30

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