Quantum ® 51-000021-00

GUDID 05060434420763

SPECTRUM MEDICAL LIMITED

Cardiopulmonary bypass system roller pump

• Primary Device ID: 05060434420763
• NIH Device Record Key: 0399a6e4-b43d-4e27-90cb-c95c75033802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum ®
• Version Model Number: Quantum Power Supply (QPS)
• Catalog Number: 51-000021-00
• Company DUNS: 516398679
• Company Name: SPECTRUM MEDICAL LIMITED
• 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: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com
• Phone: +441242650120
• Email: eusales@spectrummedical.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060434420763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173834

FDA Product Code

• DTQ: Console, Heart-Lung Machine, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-01

On-Brand Devices [Quantum ®]

• 05060434420954: Quantum Pump Frame 4 - New York (QPF4)
• 05060434420893: Resevoir Level Sensor
• 05060434420886: Pressure Sensor Assembly
• 05060434420824: Quantum Pump Frame 3 - Vienna (QPF3)
• 05060434420817: Diagnostic Exhaust for use with Quantum Dagnostic Modules
• 05060434420800: Quantum Pump Control Module (QCM)
• 05060434420794: Quantum Roller Pump - 4 inch (QRP4)
• 05060434420787: Quantum Roller Pump - 6 inch (QRP6)
• 05060434420770: Quantum Roller Pump - 8 inch (QRP8)
• 05060434420763: Quantum Power Supply (QPS)
• 05060434420756: Quantum Pump Frame 2 - Cheltenham (QPF2)
• 05060434420749: Quantum Pump Frame 1 - Blackpool (QPF1)
• 05060434420718: Extracorporeal Blood Parameter Monitor
• 05060434420701: EMulti parameter extracorporeal measurment unit
• 05060434420695: Multi parameter extracorporeal measurment unit - No Gas
• 05060434420688: Quantum Ventilation Module (QVM)
• 05060434420039: Quantum Data Management Unit
• 05060434420008: Extracorporeal Blood Parameter Monitor