Purgo

Basic Information

• Brand Name: Purgo
• Primary DI: 00860006970604
• Version / Model: PM-100A
• Company Name: MOLEKULE, INC.
• Labeler DUNS: 080508772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-11
• Public Version: 2
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 2b548d30-9394-4b42-91d5-8efa0bf2664e

Device Description

Purgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria, viruses, fungi, and particulate matter in air. Purgo may be used in medical facilities and commercial home healthcare environments

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
FRA	Purifier, Air, Ultraviolet, Medical	General Hospital	880.6500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35150	Ultraviolet ambient disinfection light	An electrically-powered light source designed to destroy bacteria and viruses in the air and/or on surfaces by emission of ultraviolet radiation into the surrounding environment. It is a mounted, or self-standing device, consisting of a tubular bulb or a unit containing the light source, and may include automatic motion sensors or timers, but does not include a user control unit or radiometers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006970604	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]