SuperNO2VA SEL-20-CE

GUDID 30889483605671

SuperNO2VA Et Mask, Adult Large

Sunmed Group Holdings, LLC

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 30889483605671
• NIH Device Record Key: c6c126e5-4100-41d9-a63d-d80ce748dfd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperNO2VA
• Version Model Number: SEL-20-CE
• Catalog Number: SEL-20-CE
• Company DUNS: 119058668
• Company Name: Sunmed Group Holdings, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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
• Phone: (800)433-2797
• Email: info@sun-med.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483605677 [Primary]
GS1	30889483605671 [Package]; Contains: 10889483605677; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173147

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 2025-04-04
• Device Publish Date: 2025-03-27

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
• 30889483606050: SuperNO2VA Et Mask, Adult Medium
• 30889483606036: SuperNO2VA Et Mask, Adult Large
• 30889483605695: SuperNO2VA Et Mask, Adult Medium
• 30889483605671: SuperNO2VA Et Mask, Adult Large