AccessGUDID - DEVICE: EVair (07640149381030)

GUDID

Device Identifier (DI) Information

Brand Name: EVair
Version or Model: M1230847
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: imtmedical ag

Primary DI Number: 07640149381030
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 483243700 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31253	Medical device air compressor	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTI	Compressor, Air, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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