ActivePure Medical Guardian

Basic Information

• Brand Name: ActivePure Medical Guardian
• Primary DI: 00860006810108
• Version / Model: F170A
• Company Name: ACTIVEPURE MEDICAL LLC
• Labeler DUNS: 118037497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-12
• Public Version: 1
• Public Version Date: 2021-05-20
• Public Version Status: New
• Public Device Record Key: b0ee7e50-f3f5-4dbb-adf2-537075a90b53

Device Description

Medical Ultraviolet Air Purifier

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: 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
FRA	Purifier, Air, Ultraviolet, Medical	General Hospital	880.6500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18113	High-efficiency filter air cleaner, mobile	A mains electricity (AC-powered) device that uses a combination of a prefilter and a high-efficiency particulate air (HEPA) filter to remove 99.97% of particles greater than 0.3 microns. This device is frequently used to prevent the transmission of tuberculosis (TB) and other diseases caused by airborne pathogens. It is designed to be moved from one location to another.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006810108	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201220	000