FDA.reportPublic FDA data

TRI-KLEEN

Primary DI
00680418000009
Brand
TRI-KLEEN
Company
TRI-DIM FILTER CORPORATION
Model
400
Device description
Tri-Kleen Air Purification System, 115 Volt, 2.5 Amp, 60 Hz. Electrical Safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Mechanical safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Made in Canada
Published
2018-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRFCleaner, Air, Medical Recirculating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRFCleaner, Air, Medical RecirculatingGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984116000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984116000HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400CAbatement Technologies, Inc.1999-06-24FRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866849000409PreviousGS10
00680418000009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866849000409008668490004098668490004090866849000409
00680418000009006804180000096804180000090680418000009

Regulatory Flags#

DUNS number
191408400
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866849000409Tri-Kleen400UV2017-09-05
00866849000416Tri-Kleen4002017-09-05
00680418000016TRI-KLEEN400UV2018-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391532530147NovaerusNOVAERUS (IRELAND) LIMITEDFRF2026-06-05
05391532531328WellairNOVAERUS (IRELAND) LIMITEDFRF2026-06-05
05391532532004NOVAERUSNOVAERUS (IRELAND) LIMITEDFRF2026-06-05
07350128750015Airsonett AIR-4Airsonett ABFRF2023-02-01
07350128750022Airsonett AIR-4 A-1100Airsonett ABFRF2023-02-01
07290018896235SU-VEIDANGIE TECHNOLOGIES LTDFRF2021-05-23
00863342000318DefenderHealth Mor At Home CbpFRF2021-03-11
00811095020015RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020022RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020077RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020084RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020138RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020152RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020169RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020176RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00811095020183RGF-BioControlsRGF ENVIRONMENTAL GROUP, INC.FRF2020-03-09
00818261022019HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-02-26
00818261022903HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-29
00818261023207HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-29
00818261023504HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-29
00818261021104HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261021401HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261021708HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261022002HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261022309HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00818261022606HEPA-CARE®ABATEMENT TECHNOLOGIES, INC.FRF2020-01-15
00680418000016TRI-KLEENTRI-DIM FILTER CORPORATIONFRF2018-09-05
00818261020510Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020534Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020640Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12