HEART™ 100619

GUDID 10889483223734

HEART™ Direct Connect Continuous Nebulizer, Adult Aerosol Mask, 8' Corrugated Tubing

SUNMED, LLC

Nebulizing system delivery set, single-use

• Primary Device ID: 10889483223734
• NIH Device Record Key: 78173870-be25-4167-84af-664253f6e783
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEART™
• Version Model Number: 100619
• Catalog Number: 100619
• 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	00709078000119 [Previous]
GS1	10889483223734 [Primary]
GS1	20889483223731 [Package]; Package: Box [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923596

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 [HEART™]

• 10889483223772: HEART™ Direct Connect Continuous Nebulizer, Adult Aerosol Mask, 8' Corrugated Tubing
• 10889483223765: HEART™ Direct Connect Continuous Nebulizer, Pediatric Aerosol Mask, 8' Corrugated Tubing
• 10889483223758: HEART™ Direct Connect Continuous Nebulizer, Super Spike Mask, 8' Corrugated Tubing
• 10889483223734: HEART™ Direct Connect Continuous Nebulizer, Adult Aerosol Mask, 8' Corrugated Tubing
• 10889483223710: HEART™ Direct Connect Continuous Nebulizer, HEART™ Only
• 10889483223703: HEART™ Continuous Nebulizer
• 10889483222324: HEART™ Continuous Nebulizer, Adult Aerosol Mask, 8' Corrugated Tubing, 10cc Syringe