AccessGUDID - DEVICE: VacStar (D678560410)

GUDID

Device Identifier (DI) Information

Brand Name: VacStar
Version or Model: 56041
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D678560410
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: The VacStar family creates vacuum that will be used in a dental facility. The VacStar system is designed for reliable operation in the modern dental facility. The system is a water ring vacuum pump used to produce the high-volume air flow required for multiple simultaneous users. The gases are vented out and the liquid and its particulates are directed down the drain. The clean water extracted during this separation process is directed back toward the VacStar where it is mixed with fresh water and then directed into the pump chamber to create vacuum. This efficient reuse of water reduces the VacStar's fresh water consumption. If the optional HydroMiser is used, water consumption can be reduced by up to 75%. In addition, VacStar NEO incorporates an efficient energy management system. This is accomplished by adding a Variable Frequency Drive (VFD) to the Vacuum Pump. This VFD adjusts the frequency of the pump to maintain the required vacuum level depending on the demand. With this balanced system, users are provided with the necessary the flow rate while conserving electricity and prolonging the life of the pump.

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?
34859	Dental suction system	An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.	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: 0f35ccf3-5317-4628-8643-6d3af2b8f6cf
Public Version Date: January 27, 2023
Public Version Number: 1
DI Record Publish Date: January 19, 2023