QUANTIEN™ C12787

GUDID 05415067000996

Diagnostic Computer

ST. JUDE MEDICAL, INC.

Cardiac catheterization laboratory computer

• Primary Device ID: 05415067000996
• NIH Device Record Key: 4e6f54a4-0887-412e-b839-669bff31b45f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTIEN™
• Version Model Number: Measurement System
• Catalog Number: C12787
• 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. Do not use if package is damaged.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067000996 [Primary]

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: 2019-03-05
• Device Publish Date: 2016-01-14

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