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MonitAir

FDA UDI

Class I (US FDA UDI)

by Monitair, Llc

Identity

Trade Name
MonitAir FDA UDI
Generic Name
Vulnerable patient home-monitoring software, professional-only FDA UDI
Device Name
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. FDA UDI
Model / Reference
1.2.9 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860012679218 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Vulnerable patient home-monitoring software, professional-only FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vulnerable patient home-monitoring software, professional-only

MonitAir by Monitair, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vulnerable patient home-monitoring software, professional-only.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monitair, Llc

Sources (1)

  • FDA UDI bd6b3a6f-49ef-434d-ba61-ede980026884 34 fields · synced May 30, 2026