FDA.reportPublic FDA data

EVair

Primary DI
76402146418092
Brand
EVair
Company
IMT Analytics AG
Model
M1230847
Device description
The medical air compressor is intended for use as an integrated, optional accessory to provide a dry, filtered, breathable compressed air supply to GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators.
Published
2020-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
76402146418092PackageGS11In Commercial Distribution
76402146418924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7640214641809276402146418092
7640214641892476402146418924

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480035934
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640214642837FlowMeter F1700.400.0012023-09-18
07640214642844FlowMeter F2700.400.0022023-09-18
07640214642851FlowMeter F1700.400.0012023-09-18
07640214642868FlowMeter F2700.400.0022023-09-18
07640214642400CITREX H4302.161.0002022-11-17
07640214642417CITREX H5304.555.0002022-11-17
07640214642448Flow Analyzer PF-300300.116.0002022-11-17
07640214642455Flow Analyzer PF-301300.116.0012022-11-17
07640214642462Flow Analyzer PF-302300.116.0022022-11-17
07640214642707Flow Analyzer PF-300 PRO700.300.0002022-11-17
07640214642363Smart Lung 2000 2 Liter302.730.1002022-11-17
07640214642370Smart Lung Adult 1 Liter300.162.1002022-11-17
07640214642387Smart Lung Infant 0.5 Liter300.400.1042022-11-17
07640214642394CITREX H3304.333.0002022-11-17
07640214641946CITREX H4302.161.0002022-11-17
07640214642165CITREX H5304.555.0002022-11-17
07640214641243Flow Analyzer PF-300300.116.0002022-11-17
07640214641250Flow Analyzer PF-301300.116.0012022-11-17
07640214641267Flow Analyzer PF-302300.116.0022022-11-17
07640214642691Easy Lung 1 Liter300.756.1002022-11-17

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