System M ® 3003-030-HB9

GUDID 05060434420169

High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Module (3003-031-005)

SPECTRUM MEDICAL LIMITED

Extracorporeal blood gas/pH monitor

• Primary Device ID: 05060434420169
• NIH Device Record Key: 3601a653-1fb8-4ddb-b8ae-fe8347992b3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System M ®
• Version Model Number: Gas Management System
• Catalog Number: 3003-030-HB9
• 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: true
• 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	05060434420169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110957

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: 2016-09-01

On-Brand Devices [System M ®]

• 05060434420237: SO2 SO2 Twin
• 05060434420206: Exhaust Module for use with Gas Modules as part of Gas Management System
• 05060434420190: High Flow - (1.0 - 7.0 L/min)
• 05060434420183: Low Flow - (0.5 - 3.0 L/min)
• 05060434420176: Ultra Low Flow - (0.05 - 0.5 L/min)
• 05060434420169: High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Module (3003-031-
• 05060434420152: Low Flow - (0.5 - 3.0 L/min) - Low Flow Gas Module (3003-030-011) & Exhaust Module (3003-031-00
• 05060434420145: Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Exhaust Module
• 05060434420084: Tube ID 3/16" x Wall 1/16" (OD 5/16")
• 05060434420077: Tube ID 1/4" x Wall 1/16" (OD 3/8")
• 05060434420060: Tube ID 1/4" x Wall 3/32" (OD 7/16")
• 05060434420053: Tube ID 3/8" x Wall 3/32" (OD 9/16")
• 05060434420046: Extracorporeal Blood Parameter Monitor
• 05060434420022: Extracorporeal Blood Parameter Monitor
• 05060434420015: Data Management Monitor