Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve 002006

GUDID 30889483570917

AirLife™ Bubble Humidifier With 6 psi Pressure Relief Valve

Sunmed Group Holdings, LLC

Non-heated respiratory humidifier

• Primary Device ID: 30889483570917
• NIH Device Record Key: a178ef38-d66b-42a2-b099-f88a8592b094
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve
• Version Model Number: 002006
• Catalog Number: 002006
• Company DUNS: 119058668
• Company Name: Sunmed Group Holdings, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752114791 [Previous]
GS1	10889483570913 [Primary]
GS1	30889483570917 [Package]; Contains: 10889483570913; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991484

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

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: 2025-02-28
• Device Publish Date: 2025-02-20

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