Quantien™ H1014670

GUDID 05415067029997

Software Upgrade Kit

ST. JUDE MEDICAL, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 05415067029997
• NIH Device Record Key: 7a6f30be-6706-44d9-a8b4-ebdb22c616d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantien™
• Version Model Number: Measurement System
• Catalog Number: H1014670
• 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	05415067029997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183099

FDA Product Code

• DQK: Computer, diagnostic, programmable

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: 2019-03-12
• Device Publish Date: 2019-03-04

On-Brand Devices [Quantien™]

• 05415067029997: Software Upgrade Kit
• 05415067023704: Measurement System
• 05415067016287: Cable Kit
• 05415067011862: Measurement System
• 05415067004659: Meaurement System
• 05415067004642: Measurement System
• 05415067004635: Measurement System
• 05415067003249: ECG/AO Cable Kit
• 05415067003232: ECG/AO Cable Kit
• 05415067003225: ECG/AO Cable Kit
• 05415067003218: ECG/AO Cable Kit
• 05415067003201: ECG/AO Cable Kit
• 05415067000996: Diagnostic Computer
• 05415067030009: Software Upgrade Kit