Quantum ® 3008-001-010

GUDID 05060434420039

Quantum Data Management Unit

SPECTRUM MEDICAL LIMITED

Patient health record information system

• Primary Device ID: 05060434420039
• NIH Device Record Key: ef782c97-c4c7-4003-8b63-455d663f0af4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum ®
• Version Model Number: QDMU
• Catalog Number: 3008-001-010
• Company DUNS: 516398679
• Company Name: SPECTRUM MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441242650120
• Email: eusales@spectrummedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060434420039 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

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