FDA.reportPublic FDA data

MonitAir

Primary DI
00860008898029
Brand
MonitAir
Company
Monitair LLC
Model
1.1.6
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
2022-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00860008898012PreviousGS10
00860008898029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008898012008600088980128600088980120860008898012
00860008898029008600088980298600088980290860008898029

GMDN Terms#

Term, Definition table
TermDefinition
Vulnerable patient home-monitoring software, professional-useA 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

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
00860008898012MonitAir1.1.52022-08-01
00860012679225MonitAir1.2.102024-11-20
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
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
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28