FDA.reportPublic FDA data

Hepa-Care®

Primary DI
00818261020909
Brand
Hepa-Care®
Company
ABATEMENT TECHNOLOGIES, INC.
Model
HC800C
Device description
Hepa-Care® Ceiling Unit, 115 Volt, 3 Amp, 60 Hz. Motor thermally protected single phase. 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
2017-08-11
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
00818261020909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818261020909008182610209098182610209090818261020909

GMDN Terms#

Term, Definition table
TermDefinition
High-efficiency filter air cleaner, stationaryA mains electricity (AC-powered) device that uses a combination of a prefilter and a high-efficiency particulate air (HEPA) filter to remove 99.97% of particles greater than 0.3 microns. This device is frequently used to prevent the transmission of tuberculosis (TB) and other diseases caused by airborne pathogens. It is designed to be stationary and is fixed in one location.

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
00818261021012Hepa-Care®UV400C2018-06-12
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

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