AirLife CHB0020

GUDID 30889483598539

WATER STERILE IN HANGING BOTTLE 2000mL

Sunmed Group Holdings, LLC

Inhalation therapy sterile water

• Primary Device ID: 30889483598539
• NIH Device Record Key: 2e73c239-30fc-41f8-877b-e10f61372344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLife
• Version Model Number: CHB0020
• Catalog Number: CHB0020
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com
• Phone: +1(800)433-2797
• Email: info@sun-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752141797 [Previous]
GS1	10889483598535 [Primary]
GS1	30889483598539 [Package]; Contains: 10889483598535; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830895

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-20
• Device Publish Date: 2025-02-12

On-Brand Devices [AirLife]

• 30889483598645: WATER STERILE FOR INHALATION 1000mL
• 30889483598539: WATER STERILE IN HANGING BOTTLE 2000mL
• 30889483598522: WATER STERILE IN HANGING BOTTLE 1000mL
• 10889483057957: AirLife™ U/Adapt-It Straight Adapter
• 30889483596085: Airlife™ Modudose™ Sterile Water for Inhalation, USP 5 ml