Quantum ® System M ® 51-000042-00

GUDID 05060434420657

Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 1.3m

SPECTRUM MEDICAL LIMITED

Extracorporeal blood gas/pH monitor

• Primary Device ID: 05060434420657
• NIH Device Record Key: 9ff2a510-0509-4d6c-9c6b-36718a69c838
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum ® System M ®
• Version Model Number: Hct / SO2 Sensor
• Catalog Number: 51-000042-00
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com
• Phone: 800 265 2331
• Email: ussales@spectrummedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060434420657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163657

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: 2018-07-06
• Device Publish Date: 2017-01-27

On-Brand Devices [Quantum ® System M ®]

• 05060434420671: Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 1.3m
• 05060434420664: Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 1.3m
• 05060434420657: Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 1.3m
• 05060434420640: Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 1.3m
• 05060434420633: Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 2m
• 05060434420626: Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 2m
• 05060434420619: Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 2m
• 05060434420602: Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 2m