Quantum ® System M ® H7XLH

GUDID 05060434420114

Tube ID 1/4" x Wall 3/32" (OD 7/16")

SPECTRUM MEDICAL LIMITED

Extracorporeal blood gas/pH monitor

• Primary Device ID: 05060434420114
• NIH Device Record Key: addb178a-b8ac-4c41-afa2-0d6f3038a588
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum ® System M ®
• Version Model Number: Flow & Emboli Sensor
• Catalog Number: H7XLH
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060434420114 [Primary]

FDA Product Code

• DRY: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

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: 2018-06-01
• Device Publish Date: 2016-09-01

On-Brand Devices [Quantum ® System M ®]

• 05060434420138: Tube ID 1/2" x Wall 3/32" (OD 11/16")
• 05060434420121: Tube ID 3/8" x Wall 3/32" (OD 9/16")
• 05060434420114: Tube ID 1/4" x Wall 3/32" (OD 7/16")
• 05060434420107: Tube ID 1/4" x Wall 1/16" (OD 3/8")
• 05060434420091: Tube ID 3/16" x Wall 1/16" (OD 5/16")