IRMA™ Airway Adapter

GUDID 17350046131603

Masimo Sweden AB

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• Primary Device ID: 17350046131603
• NIH Device Record Key: 5733ccdd-2bb7-486c-85a7-8384a3cf2084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRMA™ Airway Adapter
• Version Model Number: Airway Adapter Infant
• Company DUNS: 632369067
• Company Name: Masimo Sweden AB
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07350046131606 [Unit of Use]
GS1	17350046131603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123043

FDA Product Code

• CBS: Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-01
• Device Publish Date: 2016-08-11

On-Brand Devices [IRMA™ Airway Adapter]

• 17350046131603: Airway Adapter Infant
• 17350046131597: Airway Adapter Adult/Pediatric