Ramvac

Basic Information

• Brand Name: Ramvac
• Primary DI: D060RV12230
• Version / Model: RV1223
• Company Name: Dentalez Alabama, Inc.
• Labeler DUNS: 806326521
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-05
• Public Version: 1
• Public Version Date: 2024-11-13
• Public Version Status: New
• Public Device Record Key: 47c31a3a-1bbf-4884-b40c-22ea8561ba17

Device Description

AERAS 12 DRY VAC ONLY, 12 USER, 230V 3PH

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63829	Dental suction system pump	An electrically-powered device intended to be permanently integrated within a dental suction/delivery system to generate a vacuum as part of the aspiration of water, blood, saliva, and tooth debris from the oral cavity of a patient and/or for connection to a dental cuspidor. It may or may not be designed to handle fluids (i.e., may be a wet or dry pump). It is not a complete system and does not include any patient contact devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D060RV12230	HIBCC