FDA.reportPublic FDA data

MonitAir

Primary DI
00860012679225
Brand
MonitAir
Company
Monitair LLC
Model
1.2.10
Device 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.
Published
2024-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012679218PreviousGS10
00860012679225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012679218008600126792188600126792180860012679218
00860012679225008600126792258600126792250860012679225

GMDN Terms#

Term, Definition table
TermDefinition
Vulnerable patient home-monitoring software, professional-onlyA software program intended to allow healthcare professionals to remotely observe and assess the physical/mental state and environment of a vulnerable/geriatric patient (e.g., patient with dementia) whilst at home. It is intended for real-time analysis and recording of data from devices in the home (motion sensors, medical monitoring equipment) and uses algorithms to highlight patterns of concerning behaviour or physiological readings. The data is intended to be reviewed remotely by a healthcare professional so that appropriate actions can be coordinated (e.g., contact next of kin, call paramedic). It is not intended for diagnosis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8334663698info@monitairhealth.com

Regulatory Flags#

DUNS number
131412021
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012679270MonitAir1.3.x2025-05-13
00860012679263MonitAir1.2.142025-03-18
00860012679256MonitAir1.2.132025-02-28
00860012679249MonitAir1.2.122025-01-01
00860012679232MonitAir1.2.112024-12-23
00860008898043MonitAir1.1.82023-01-06
00860008898050MonitAir1.1.92023-01-20
00860008898098MonitAir1.2.32023-09-26
00860008898081MonitAir1.2.22023-07-14
00860008898074MonitAir1.2.12023-07-11
00860008898067MonitAir1.2.02023-05-09
00860008898036MonitAir1.1.72022-09-12
00860008898029MonitAir1.1.62022-09-07
00860008898012MonitAir1.1.52022-08-01
00860012679201MonitAir1.2.82024-11-04
00860012679218MonitAir1.2.92024-11-04
00198715136333MonitAir1.2.72024-07-02
00198168370179MonitAir1.2.62024-03-20
00198168116760MonitAir1.2.52023-12-19
00198168299500MonitAir1.2.42023-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04