FDA.report

UV Smart

Primary DI
08719326634265
Brand
UV Smart
Company
UV Smart Technologies B.V.
Model
D25V2
Published
2022-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MECDisinfector, Medical Devices

Product Code Classifications

CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08719326634265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08719326634265087193266342658719326634265

GMDN Terms

TermDefinition
Ultraviolet disinfection lightAn 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
493966010
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08719326634272UV SmartD60V12022-06-06

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