Circulaire™ 0330

GUDID 20889483227616

Circulaire™ II Aerosol Drug Delivery System with Comfort Soft Plus™ Adult Non-Vented Mask, Mouthpiece, B/V Filter

SUNMED, LLC

Nebulizing system delivery set, single-use

• Primary Device ID: 20889483227616
• NIH Device Record Key: 0c94e850-4c5a-4482-898e-b18f60b61006
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circulaire™
• Version Model Number: 0330
• Catalog Number: 0330
• 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
• 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	00709078000782 [Previous]
GS1	10889483227619 [Primary]
GS1	20889483227616 [Package]; Contains: 10889483227619; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926055

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: 2025-12-26
• Device Publish Date: 2025-12-18

On-Brand Devices [Circulaire™]

• 20889483227661: Circulaire™ II Aerosol Drug Delivery System with Extra Reservoir Bag, B/V Filter
• 20889483227654: Circulaire™ II Aerosol Drug Delivery System with Adult Non-Vented Mask, Mouthpiece, B/V Filter
• 20889483227616: Circulaire™ II Aerosol Drug Delivery System with Comfort Soft Plus™ Adult Non-Vented Mask, M