NPure System

Basic Information

• Brand Name: NPure System
• Primary DI: 00850017374096
• Version / Model: 100-1500
• Company Name: NEAUVIA NORTH AMERICA, INC.
• Labeler DUNS: 117030786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-24
• Public Version: 1
• Public Version Date: 2021-10-04
• Public Version Status: New
• Public Device Record Key: f3fb4947-da2f-4ca9-b3b8-fdbb5f26bf14

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: No
• 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
LRJ	Disinfectant, Medical Devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31311	Room dehumidifier	A mains electricity (AC-powered) device intended to remove moisture from the ambient air. This is a stationary device designed to be placed in one place in a room, typically in a hospital, institution, home, or office environment; it can be physically lifted/wheeled and moved to another position or room. It typically consists of an electric motor, an air/moisture filtration system, a reservoir for water collection and operating controls. The captured moisture is collected in the reservoir which is emptied on a regular basis, or which can drain directly via tubing into a drainage system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850017374096	GS1