IRMA™ CO2 Root 4429

GUDID 07350046132030

Masimo Sweden AB

Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide Patient monitoring system module, carbon dioxide

• Primary Device ID: 07350046132030
• NIH Device Record Key: 22a99228-63c1-4730-93d4-e53cfea80f6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRMA™ CO2 Root
• Version Model Number: CO2 Root
• Catalog Number: 4429
• Company DUNS: 632369067
• Company Name: Masimo Sweden AB
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350046132030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123043

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 2019-04-10
• Device Publish Date: 2019-04-02

Devices Manufactured by Masimo Sweden AB

• 07350046132139 - ISA™ Gas Exhaust Kit: 2021-09-22
• 07350046132658 - NomoLine™ Comfort HH Adult Nasal CO2 Cannula: 2021-01-26
• 07350046132665 - NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula: 2021-01-26
• 07350046132672 - NomoLine™ Comfort HH Adult Nasal CO2 Cannula with O2: 2021-01-26
• 07350046132689 - NomoLine™ Comfort HH Adult Nasal/Oral CO2 Cannula with O2: 2021-01-26
• 07350046132290 - ISA™ CO2: 2021-01-18
• 07350046131996 - Radius PCG™: 2020-10-27
• 07350046132009 - Radius PCG™: 2020-10-27