LightStrike+

Basic Information

• Brand Name: LightStrike+
• Primary DI: 00814122020163
• Version / Model: MXSUV1-FT
• Company Name: Xenex Disinfection Services Inc.
• Labeler DUNS: 039302870
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-06
• Public Version: 1
• Public Version Date: 2023-11-14
• Public Version Status: New
• Public Device Record Key: 03f509ed-a6d9-4493-8d92-d7d56a618307

Device Description

Whole Room Microbial Reduction Device

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
QXJ	Whole Room Microbial Reduction Device	General Hospital	880.6510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65824	Ultraviolet device microbial reduction unit	A portable electrically-powered device intended to reduce microbial and organic soil loads on the surface of noninvasive medical equipment, and other non-porous contact surfaces, using ultraviolet C (UVC) light; it is not intended for device disinfection. It includes UVC lights and controls and is intended to be placed in proximity to the devices to be decontaminated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814122020163	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN230007	000