Defender

Primary DI
00863342000318
Brand
Defender
Company
Health Mor At Home Cbp
Model
D11NA
Device description
"The Defender Room Air Cleaner (""Defender"") is a portable, mechanical air filtration systemdesigned for single use int he home environment. It is configured as a circular unit with aprotective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiencyand particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses andodors. During operation, air is drawn into the lower assembly, passes through the upperassembly providing a 360-degree flow of air. The unit is equipped with a scent generatorpowered by a small heating element. Outlet filtered air passes through the scent generatorand out from the top of the unit.The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron insize. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, moldand pet allergens. The Defender is also intended to remove Tobacco smoke and otherhousehold odors."
Published
2021-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
K010616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010616000DEFENDER ROOM AIR CLEANER, MODEL RAC-4000AHmi Industries, Inc.2001-03-28FRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863342000318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863342000318008633420003188633420003180863342000318

GMDN Terms#

Term, Definition table
TermDefinition
High-efficiency filter air cleaner, mobileA 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 moved from one location to another.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005146535
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
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