FDA.reportPublic FDA data

Hepa-Care®

Primary DI
00818261020534
Brand
Hepa-Care®
Company
ABATEMENT TECHNOLOGIES, INC.
Model
HC600FTF-G
Device description
Hepa-Care® Portable Unit, 220-240 Volt 2 Amp 50 Hz G plug. Motor thermally protected single phase. Made in Canada
Published
2018-06-12
Public version status
New
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
00818261020534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818261020534008182610205348182610205340818261020534

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
16788894200iaqinfo@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
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
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
00680418000009TRI-KLEENTRI-DIM FILTER CORPORATIONFRF2018-09-05
00680418000016TRI-KLEENTRI-DIM FILTER CORPORATIONFRF2018-09-05
00818261020510Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020640Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12