VixOne™ 0310

GUDID 20889483229993

VixOne™ Nebulizer Mask Kit, Adult

SUNMED, LLC

Nebulizing system delivery set, single-use

• Primary Device ID: 20889483229993
• NIH Device Record Key: f1e53acb-3934-4bc7-a898-416d6cd401fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VixOne™
• Version Model Number: 0310
• Catalog Number: 0310
• Company DUNS: 069009268
• Company Name: SUNMED, 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: 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	00709078000539 [Previous]
GS1	10889483229996 [Primary]
GS1	20889483229993 [Package]; Contains: 10889483229996; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800562

FDA Product Code

• CAF: Nebulizer (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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [VixOne™]

• 20889483231231: VixOne™ Small Volume Nebulizer
• 20889483230043: VixOne™ Nebulizer Mask Kit, Pediatric
• 20889483230036: VixOne™ Nebulizer Mask Kit, Pediatric
• 20889483230029: VixOne™ Super Spike™ Nebulizer Mask Kit
• 20889483230012: VixOne™ Super Spike™ Nebulizer Mask Kit
• 20889483229993: VixOne™ Nebulizer Mask Kit, Adult
• 20889483229986: VixOne™ Nebulizer Mask Kit, Adult
• 20889483227715: VixOne™ Small Volume Nebulizer
• 20889483227647: VixOne™ Small Volume Nebulizer
• 20889483226602: VixOne™ Nebulizer (Bulk)
• 20889483224868: VixOne™ Disposable Nebulizer
• 20889483224530: VixOne™ Small Volume Nebulizer
• 20889483224141: VixOne™ Small Volume Nebulizer
• 20889483224134: VixOne™ Small Volume Nebulizer
• 20889483224127: VixOne™ Small Volume Nebulizer
• 20889483224110: VixOne™ Small Volume Nebulizer
• 20889483223946: VixOne™ Small Volume Nebulizer
• 20889483223939: VixOne™ Small Volume Nebulizer
• 20889483222093: VixOne™ Reusable Nebulizer, Mouthpiece, Tee, 7' Supply Tubing
• 20889483222062: VixOne™ Reusable Nebulizer