Duns Number:483243700
Device Description: The medical air compressor is intended for use as an integrated, optional accessory to pro 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.
Catalog Number
-
Brand Name
EVair
Version/Model Number
M1230847
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
c278e6af-86fd-4812-8ee2-11093f8c5049
Public Version Date
February 28, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
07640149380804
Quantity per Package
1
Contains DI Package
07640149381030
Package Discontinue Date
December 31, 2019
Package Status
Not in Commercial Distribution
Package Type
Cardboard carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |