AccessGUDID - DEVICE: Mojave LT (D678LT30)

GUDID

Device Identifier (DI) Information

Brand Name: Mojave LT
Version or Model: LT3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D678LT30
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: The MOJAVE creates vacuum that will be used in a dental facility. This vacuum system is designed for reliable operation in the modern dental facility. The system uses a 100% oil-less vacuum pump to produce the high-volume air flow required for multiple simultaneous users while the separator tank ensures that no liquids enter the pump. In addition, MOJAVE incorporates an efficient energy management system. This is accomplished by adding a Variable Frequency Drive (VFD) to the Vacuum Pump, which is controlled by a Master Controller. This controller automatically adjusts the frequency of the pump to maintain the required vacuum level depending on the needs of your dental facility. With this balanced system, each user always has the flow rate necessary to do the job 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: 971feb45-283a-4a27-89f4-f510a3837bf2
Public Version Date: February 02, 2023
Public Version Number: 1
DI Record Publish Date: January 25, 2023