Pedi-Neb™ 0385

GUDID 20889483227388

Pedi-Neb™ Nasal Nebulizer

SUNMED, LLC

Nebulizing system delivery set, single-use

• Primary Device ID: 20889483227388
• NIH Device Record Key: 259d7384-a432-4ceb-8ad3-3a3334cf5464
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedi-Neb™
• Version Model Number: 0385
• Catalog Number: 0385
• 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	00709078001611 [Previous]
GS1	10889483227381 [Primary]
GS1	20889483227388 [Package]; Contains: 10889483227381; Package: Box [25 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 [Pedi-Neb™ ]

• 20889483495749: Pedi-Neb™ Nasal Nebulizer
• 20889483227388: Pedi-Neb™ Nasal Nebulizer
• 20889483223588: Pedi-Neb™ Small Volume Nebulizer, Pacifier with Adaptor