SuperNO2VA SNL-20

GUDID 30889483605985

SuperNO2VA Nasal PAP Ventilation Device, Large

Sunmed Group Holdings, LLC

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 30889483605985
• NIH Device Record Key: ba01ca7e-07be-4a3c-b93a-acd56202ea6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperNO2VA
• Version Model Number: SNL-20
• Catalog Number: SNL-20
• Company DUNS: 119058668
• Company Name: Sunmed Group Holdings, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com
• Phone: (800)433-2797
• Email: info@sun-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752145450 [Previous]
GS1	10889483605981 [Primary]
GS1	30889483605985 [Package]; Contains: 10889483605981; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163277

FDA Product Code

• BSJ: Mask, Gas, Anesthetic

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: 2025-02-27
• Device Publish Date: 2025-02-19

On-Brand Devices [SuperNO2VA]

• 30889483606043: SuperNO2VA ET SYSTEM, Adult Medium
• 30889483606029: SuperNO2VA ET SYSTEM, Adult Large
• 30889483166301: SuperNO2VA Nasal PAP Ventilation System, Medium
• 30889483166295: SuperNO2VA Nasal PAP Ventilation System, Large
• 30889483605992: SuperNO2VA Nasal PAP Ventilation Device, Medium
• 30889483605985: SuperNO2VA Nasal PAP Ventilation Device, Large
• 30889483605688: SuperNO2VA Et Mask, Adult Medium
• 30889483605664: SuperNO2VA Et Mask, Adult Large