FDA.reportPublic FDA data

The Pyure Company

Primary DI
00819355020218
Brand
The Pyure Company
Company
The Pyure Company Inc
Model
MDU/RX
Catalog number
00819355020218
Device description
Medical Ultraviolet Air Cleaner
Published
2021-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRAPurifier, Air, Ultraviolet, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRAPurifier, Air, Ultraviolet, MedicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133800000ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLIHgi Industires2014-12-19FRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819355020218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819355020218008193550202188193550202180819355020218

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet air cleanerAn air purification device intended to destroy airborne pathogens and pollutants (e.g., volatile organic compounds) in the ambient air of an enclosed room/area using ultraviolet (UV) radiation light applied to the air while circulated within a chamber. It consists of an electrically-powered unit with an enclosed optic chamber into which air is drawn and exposed to UV energy before being recirculated into the room, whereby pathogens/pollutants in the aspirated air are destroyed by UV radiation and by hydroxyl radicals produced by the reaction between UV energy and water vapour molecules.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
561-735-3701acastillo@pyureco.com

Regulatory Flags#

DUNS number
117749345
Device count
1
Serial number
true
Manufacturing date on label
true

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