FDA.reportPublic FDA data

EVair

Primary DI
00195278366078
Brand
EVair
Company
DATEX-OHMEDA INC
Model
M1230847
Device description
CPRSR 110-120V 60HZ EVAIR BCG
Published
2021-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BTICompressor, air, portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278366078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278366078001952783660781952783660780195278366078

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129501685
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682119320Well Baby BassinetBN42016-07-29
00840682119337Well Baby BassinetBN72016-07-29
00840682119344Well Baby BassinetBN32016-07-29
00840682119375Well Baby BassinetBN12016-07-29
00840682119399Well Baby BassinetBN22016-07-29
00840682119429Well Baby BassinetBN62016-07-29
00840682119436Well Baby BassinetBN92016-07-29
00840682119467Well Baby BassinetBN82016-07-29
00840682119481Well Baby BassinetBN102016-07-29
00840682119498Well Baby BassinetBN52016-07-29
00840682102353Aestiva GS7900 2 vap art arm2015-09-23
00840682102261Aespire79002015-09-23
00840682102285AespireView2015-09-23
00840682102308Aestiva79002015-09-23
00840682102339AestivaMRI2015-09-23
00840682102360Aestiva GS7900 3 vap art arm2015-09-23
00840682145596Carestation 750A12023-04-04
00840682146425Carestation 750cA12023-04-04
00195278579157ET CONTROL OPTIONAISYS CS22022-07-21
00195278588128AisysCS2 WITH ET CONTROL2022-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344214723MEDLINEMEDLINE INDUSTRIES, INC.BTI2026-07-13
00810050863438MedPakLIFEPORT, LLCBTI2026-05-06
00038214001773Pulmo-Mist CompressorNIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001780Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001797Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00762860000582OMBRA* Table Top Compressor System Trudell Medical InternationalBTI2025-11-06
10197344149070MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149087MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149094MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149100MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344135592MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-14
10197344135585MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154180MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154197MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154203MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344135578MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-07-28
00197344042817MedlineMEDLINE INDUSTRIES, INC.BTI2024-02-16
00810050862745Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2024-01-11
00810050862707Utility Pedestal AssemblyLIFEPORT, LLCBTI2023-12-15
00810050862691Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-12-08
00810050862677Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-11-10
00810050862615Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862622Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862523Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862530Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862547Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862431Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-06-06
00810050862363Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862370Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862325Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07