IRMA™ CO2 Root 4429

GUDID 07350046132030

Masimo Sweden AB

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