ISA™ CO2 989803203031

GUDID 07350046132115

Masimo Sweden AB

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• Primary Device ID: 07350046132115
• NIH Device Record Key: c02de9e2-dd45-4497-a9b5-a1211301a6a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISA™ CO2
• Version Model Number: CO2
• Catalog Number: 989803203031
• 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	07350046132115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171121

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

On-Brand Devices [ISA™ CO2]

• 07350046131804: CO2 LEMO
• 07350046131798: CO2 ROOT
• 07350046131781: CO2
• 07350046132115: CO2
• 07350046132290: CO2