MonitAir

GUDID 00860012679249

MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.

Monitair LLC

Vulnerable patient home-monitoring software, professional-only

• Primary Device ID: 00860012679249
• NIH Device Record Key: 6330a829-6a1a-49cd-8226-c7ca2eb612b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MonitAir
• Version Model Number: 1.2.12
• Company DUNS: 131412021
• Company Name: Monitair LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com
• Phone: 8334663698
• Email: info@monitairhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012679232 [Previous]
GS1	00860012679249 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2025-01-09
• Device Publish Date: 2025-01-01

On-Brand Devices [MonitAir]

• 00860008898005: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898012: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898029: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898036: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898067: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898074: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898081: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898098: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00198168299500: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00198168116760: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00198168370179: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00198715136333: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860012679218: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860012679201: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860012679225: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898050: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860008898043: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860012679232: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860012679249: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860012679256: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860012679263: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi
• 00860012679270: MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedi