Quantum 51-000095-00

GUDID 05060434422316

SPECTRUM MEDICAL LIMITED

Cardiopulmonary bypass system roller pump

• Primary Device ID: 05060434422316
• NIH Device Record Key: 7326f5e2-a9fa-4c34-9a59-9c38e9826d39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum
• Version Model Number: Quantum Pump Frame 6 - Toronto (QPF6)
• Catalog Number: 51-000095-00
• 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: 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: +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 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
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060434422316 [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: 1
• Public Version Date: 2020-04-22
• Device Publish Date: 2020-04-14

On-Brand Devices [Quantum]

• 05060434420879: Quantum Anesthetic Gas Sensor (QAN1)
• 05060434421944: Quantum Smart Occluder - Right Hand (QSOR)
• 05060434420732: Quantum Smart Occluder - Left hand (QSOL)
• 05060434422125: ID 1/2" x Wall 3/32" (OD 11/16") 3.0m
• 05060434422118: ID 3/8" x Wall 3/32" (OD 9/16") 3.0m
• 05060434422101: ID 1/4" x Wall 3/32" (OD 7/16") 3.0m
• 05060434422095: ID 1/4" x Wall 1/16" (OD 3/8") 3.0m
• 05060434422088: ID 3/16" x Wall 1/16" (OD 5/16") 3.0m
• 05060434422019: ID 1/2" x Wall 3/32"(OD11/16") 0.75m
• 05060434422002: ID 3/8" x Wall 3/32" (OD 9/16") 0.75m
• 05060434421999: ID 1/4" x Wall 3/32" (OD 7/16") 0.75m
• 05060434421982: ID 1/4" x Wall 1/16" (OD 3/8") 0.75m
• 05060434421975: ID 3/16" x Wall 1/16" (OD 5/16") 0.75m
• 05060434421883: ID 1/2" x Wall 3/32" (OD 11/16") 2.0m
• 05060434421876: ID 3/8" x Wall 3/32" (OD 9/16") 2.0m
• 05060434421869: ID 1/4" x Wall 3/32" (OD 7/16") 2.0m
• 05060434421852: ID 1/4" x Wall 1/16" (OD 3/8") 2.0m
• 05060434421845: ID 3/16" x Wall 1/16" (OD 5/16") 2.0m
• 05060434422026: Quantum Workstation Lite (QWSL)
• 05060434422316: Quantum Pump Frame 6 - Toronto (QPF6)
• 05060434422262: Quantum Pump Frame 5 - Charlotte (QPF5)
• 05060434421838: Quantum Centrifugal Drive High Pressure (QCD37)
• 05060434421821: Quantum Centrifugal Drive Medium Pressure (QCD22)
• 05060434422972: Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 1.5m (QF25) Right Angled
• 05060434422965: Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.5m (QF24) Right Angled
• 05060434422958: Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 1.5m (QF23) Right Angled
• 05060434422941: Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 1.5m (QF22) Right Angled
• 05060434422934: Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 1.5m (QF21)Right Angled
• 05060434422927: Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 0.6m (QF20) Right Angled
• 05060434422910: Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 0.6m (QF19) Right Angled
• 05060434422903: Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 0.6m (QF18) Right Angled
• 05060434422897: Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 0.6m (QF17) Right Angled
• 05060434422880: Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 0.6m (QF16) Right Angled
• 05060434423276: Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 1.2m (QF35)
• 05060434423269: Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.2m (QF34)
• 05060434423252: Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 1.2m (QF33)
• 05060434423245: Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 1.2m (QF32)
• 05060434423238: Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 1.2m (QF31)
• 05060434423221: Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 0.75m (QF30) Right Angled
• 05060434423214: Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 0.75m (QF29) Right Angled
• 05060434423207: Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 0.75m (QF28) Right Angled
• 05060434423191: Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 0.75m (QF27) Right Angled
• 05060434423184: Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 0.75m (QF26) Right Angled
• 05060434422743: Quantum Ventilation Module - NIST (Tube Mount)
• 05060434422736: Quantum Ventilation Module - DISS (Tube Mount)
• 05060434422071: Quantum Ventilation Module - DISS (Hook Mount)
• 05060434422064: Quantum Ventilation Module - NIST (Hook Mount)
• 05060434423443: Quantum Smart Occluder - Right Hand
• 05060434423436: Quantum Smart Occluder - Left hand
• 05060434423122: Quantum Pump Frame 5 - Charlotte