LightStrike+

Primary DI
00814122020163
Brand
LightStrike+
Company
Xenex Disinfection Services Inc.
Model
MXSUV1-FT
Device description
Whole Room Microbial Reduction Device
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
QXJWhole Room Microbial Reduction Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXJWhole Room Microbial Reduction DeviceGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230007000LightStrike+ (MXSUV1-SL and MXSUV1-FT)Xenex Disinfection Services, Inc.2023-09-01QXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814122020163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814122020163008141220201638141220201630814122020163

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet device microbial reduction unitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039302870
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814122020170LightStrike+MXSUV1-SL2023-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814122020170LightStrike+Xenex Disinfection Services Inc.QXJ2023-11-06