AccessGUDID - DEVICE: AirStar Clinical Air Compressor (D678AS60C0)

GUDID

Device Identifier (DI) Information

Brand Name: AirStar Clinical Air Compressor
Version or Model: AS60C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D678AS60C0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: AirStar Clinical Air Compressor’s compressed air station is designed to supply compressed air in order to operate dental units or for similar applications. The compressed air station has been designed for operation in dry, ventilated rooms.

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):	No
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
NRD	Unit, Operative Dental, Accessories

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: 4d9b8b81-de6b-412a-84a6-403523edba56
Public Version Date: June 22, 2023
Public Version Number: 1
DI Record Publish Date: June 14, 2023