FDA.reportPublic FDA data

EVair

Primary DI
07640149381023
Brand
EVair
Company
imtmedical ag
Model
M1230849
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
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
07640149380750PackageGS11In Commercial Distribution
07640149381023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640149380750076401493807507640149380750
07640149381023076401493810237640149381023

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
483243700
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640149381115bellavista10002018-09-06
07640149383836imtmedical302.578.000302.578.0002021-01-13
07640149380767imtmedical301.328.010301.328.0102021-01-13
07640149381580imtmedical301.470.010301.470.0102021-01-13
07640149383959imtmedical302.578.000302.578.0002021-01-13
07640149381030EVairM12308472016-09-24

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Primary DI, Brand, Company table
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