UniHEART™ 100850

GUDID 10889483229613

UniHEART™ Low Flow Continuous Nebulizer, UniHEART™ Only

SUNMED, LLC

Nebulizing system delivery set, single-use

• Primary Device ID: 10889483229613
• NIH Device Record Key: bf6aea39-0987-4828-b7ad-a512bf52389a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniHEART™
• Version Model Number: 100850
• Catalog Number: 100850
• 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
• 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	00709078000287 [Previous]
GS1	10889483229613 [Primary]
GS1	20889483229610 [Package]; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943600

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: 2025-12-23
• Device Publish Date: 2025-12-15

On-Brand Devices [UniHEART™]

• 10889483229613: UniHEART™ Low Flow Continuous Nebulizer, UniHEART™ Only
• 10889483227558: UniHEART™ Low Flow Continuous Nebulizer, Super Spike Mask, 7' Tubing with Threaded Nut
• 10889483222317: UniHEART™ Low Flow Continuous Nebulizer, Adult Mask, 7' Tubing with Threaded Nut