FDA.reportPublic FDA data

myAir

Primary DI
00840193400115
Brand
myAir
Company
RESMED CORP.
Model
22245
Catalog number
22245
Device description
MYAIR FOR IOS APP
Published
2021-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2
MNRVentilatory Effort RecorderAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840193400115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840193400115008401934001158401934001150840193400115

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a ventilator. A basic set of applications programs and routines are included with the ventilator and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-424-0737reception@resmed.com

Regulatory Flags#

DUNS number
080243150
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840193400276AirView22240222402024-10-02
00840193400122myAir22246222462021-07-28
00840193400191ResScan313372023-03-07
08401934313389ResScan313382023-02-24
08401934313396ResScan313392023-02-24
00840193400108AirView22240222402021-11-30
00840193400023RMDpulse222542021-04-13
00840193400030RMDpulse222532021-04-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
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04250413410637SOMNOscreen HDSOMNOmedics AGMNR2026-08-13
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