AirLife™ 0375

GUDID 20889483223977

AirLife™ Super Spike™ Aerosol Masks

SUNMED, LLC

Aerosol face mask, non-rebreathing

• Primary Device ID: 20889483223977
• NIH Device Record Key: b52b6411-f78c-4a88-9830-fc59b3af91ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLife™
• Version Model Number: 0375
• Catalog Number: 0375
• Company DUNS: 069009268
• Company Name: SUNMED, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: 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	00709078002687 [Previous]
GS1	10889483223970 [Primary]
GS1	20889483223977 [Package]; Contains: 10889483223970; Package: Box [50 Units]; In Commercial Distribution

FDA Product Code

• BYG: Mask, Oxygen

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: 2025-12-29
• Device Publish Date: 2025-12-19

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• 10889483226513: AirLife™ Large Tube Tackles
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• 10889483233221: AirLife™ Transport Set, Norman Elbow, 3 L Latex Free Breathing Bag with Cut Tail, 7' KROT with
• 10889483221907: AirLife™ Composite Respiratory Kits, 1- High Flow Humidifier, 1- Salter-Style™ Soft Oxygen C
• 10889483221891: AirLife™ Composite Respiratory Kits, 1- High Flow Humidifier, 1- Salter-Style™ Soft Oxygen C
• 20889483497484: AirLife™ Disposable Respiratory Circuit, 72" Pediatric Circuit
• 20889483230364: AirLife™ CO2/O2 Mask, Adult Elongated CO2/O2 Mask, 7' Tubing with Thread Nut, Swivel GSE, 10'
• 20889483229702: AirLife™ HME Filter, Inline Mini HME Filter with Sampling Port
• 20889483229276: AirLife™ Barbed Tubing Adapter (Nipple & Nut)
• 20889483225667: AirLife™ Adaptor, 22mm ID x 19mm OD
• 20889483225636: AirLife™ Adaptor, 22/15mm x 22mm OD, Bulk
• 20889483225278: AirLife™ Flex Extender, 5.2" Flex Tubing, 15 mm OD x 22 /15 mm ID with Capped Gas Sampling Por
• 20889483224165: AirLife™ Aerosol Mask, Pediatric
• 20889483222390: AirLife™ CO2/O2 Mask, Adult Elongated CO2/O2 Mask
• 20889483221157: AirLife™ Gas Sampling Line with Reflective Luer, 10' PVC, .038" ID X .107" OD, Swivel Elbow, R
• 20889483054328: AirLife™ Bubble Humidifier
• 20889483270582: AirLife™ Aerosol Drug Delivery System, Kit Contains: 1- Reusable VixOne™ Super Spike™ Mask
• 20889483229429: AirLife™ Concentrator Humidifier Adapter, 15" O Tubing with Threaded Nut Connector
• 20889483225650: AirLife™ Adapter, Modified Washington Tee
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• 20889483224158: AirLife™ Aerosol Mask, Adult
• 20889483223977: AirLife™ Super Spike™ Aerosol Masks
• 20889483221744: AirLife™ PEP Devices (Positive Expiratory Pressure) Accessory Kit
• 20889483221058: AirLife™ Aerosol Drug Delivery System, Kit Contains: 1- Reusable VixOne™, 1 - Nebulizer Comp
• 20889483054335: AirLife™ Bubble Humidifier, High Flow