FDA.reportPublic FDA data

Hepa-Care®

Primary DI
00818261021012
Brand
Hepa-Care®
Company
ABATEMENT TECHNOLOGIES, INC.
Model
UV400C
Device description
Hepa-Care® Ceiling Unit, 120 VAC, 2 Amp, 60 Hz. Electrical safety: UL 1598:2008/R:2012-10 & CSA C22.2 No. 250.0:2008/R2013-10. Mechanical Safety: UL 1598:2008/R:2012-10 & CSA C22.2 No. 250.0:2008/R2013-10. Made in Canada
Published
2018-06-12
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
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
00818261021012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818261021012008182610210128182610210120818261021012

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet germicidal lightA mains electricity (AC-powered) device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation from a light source, consisting of, e.g., a low pressure mercury (Hg) vapour tube that emits ultraviolet radiation as well as visible light. It may also destroy bacteria by other means, thereby reducing concentration of airborne droplet nuclei that carry live microorganisms. It could typically be used to prevent the spreading of tuberculosis (TB).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18006349091iaqinfo@abatement.com

Regulatory Flags#

DUNS number
173503806
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818261021005Hepa-Care®UV800F2017-08-11
00818261021036Hepa-Care®UV400C-PT2018-06-12
00818261022019HEPA-CARE®HC800FDTF2020-02-26
00818261022903HEPA-CARE®HC500FD2020-01-29
00818261023207HEPA-CARE®HC500FDUV2020-01-29
00818261023504HEPA-CARE®HC500CD2020-01-29
00818261021104HEPA-CARE®HC400FD2020-01-15
00818261021401HEPA-CARE®HC400FDUV2020-01-15
00818261021708HEPA-CARE®HC400CD2020-01-15
00818261022002HEPA-CARE®HC800FD2020-01-15
00818261022309HEPA-CARE®HC800FDUV2020-01-15
00818261022606HEPA-CARE®HC800CD2020-01-15
00818261020510Hepa-Care®HC600FTF2018-06-12
00818261020534Hepa-Care®HC600FTF-G2018-06-12
00818261020640Hepa-Care®HC600FTS-G2018-06-12
00818261020817Hepa-Care®HC800FTF2018-06-12
00818261020893Hepa-Care®HC800FTFULPA-G2018-06-12
00818261020206Hepa-Care®HC400F2017-09-05
00818261020305Hepa-Care®HC400FUV2017-09-05
00818261020312Hepa-Care®HC400FUVTF2017-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00680418000009TRI-KLEENTRI-DIM FILTER CORPORATIONFRF2018-09-05
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
00818261020817Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020893Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12