MiniHEART™ 100613A

GUDID 10889483227497

MiniHEART™-HiFlo™ Continuous Nebulizer, Pediatric Aerosol Mask, 7' Tubing with Threaded Nut

SUNMED, LLC

Nebulizing system delivery set, single-use

• Primary Device ID: 10889483227497
• NIH Device Record Key: 238f2b63-9353-44d2-8f4d-6b8b2bf98814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniHEART™
• Version Model Number: 100613A
• Catalog Number: 100613A
• 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
• Phone: 1-800-433-2797
• Email: info@sun-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078000256 [Previous]
GS1	10889483227497 [Primary]
GS1	20889483227494 [Package]; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920443

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 [MiniHEART™]

• 10889483227534: MiniHEART™-LoFlo™ Continuous Nebulizer with IV Port, Adult Valved Tee, 7' Tubing, 8' Corruga
• 10889483227503: MiniHEART™-HiFlo™ Continuous Nebulizer, Super Spike™ Mask, 7' Tubing
• 10889483227497: MiniHEART™-HiFlo™ Continuous Nebulizer, Pediatric Aerosol Mask, 7' Tubing with Threaded Nut
• 10889483227480: MiniHEART™-HiFlo™ Continuous Nebulizer, Adult Aerosol Mask, 7' Tubing with Threaded Nut
• 10889483227473: MiniHEART™-HiFlo™ Continuous Nebulizer, MiniHEART™ Only
• 10889483227466: MiniHEART™-LoFlo™ Continuous Nebulizer with IV Port, Neonatal Valved Tee, 7' Tubing, 8' Corr
• 10889483227459: MiniHEART™-LoFlo™ Continuous Nebulizer
• 10889483227442: MiniHEART™-LoFlo™ Continuous Nebulizer with IV Port, 7' Tubing with Threaded Nut, 6" Flex Tu
• 10889483227435: MiniHEART™-LoFlo™ Continuous Nebulizer with IV Port, MiniHEART™ Only