FDA.reportPublic FDA data

Novaerus

Primary DI
05391532530147
Brand
Novaerus
Company
NOVAERUS (IRELAND) LIMITED
Model
Defend 1050
Device description
Medical Recirculating Air Cleaner, free standing, AC powered. The device is a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. Other marketing name: NV1050
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

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
K200321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200321000Novaerus NV1050Novaerus Us, Inc.2020-12-28FRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391532530147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391532530147053915325301475391532530147

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.

Contacts#

Phone, Email table
PhoneEmail
803-2374072llawlor@wellair.ie

Regulatory Flags#

DUNS number
985089944
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391532531328WellairPro XL2026-06-05
05391532532004NOVAERUSDEFEND 4002026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00818261020534Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12
00818261020640Hepa-Care®ABATEMENT TECHNOLOGIES, INC.FRF2018-06-12