FDA.reportPublic FDA data

Illuvia

Primary DI
00852348007896
Brand
Illuvia
Company
AEROBIOTIX USA LLC
Model
Illuvia HEPA Filter
Device description
Air purification HEPA filter
Published
2021-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZHApparatus, Air Handling, Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZHApparatus, Air Handling, RoomGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852348007896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852348007896008523480078968523480078960852348007896

GMDN Terms#

Term, Definition table
TermDefinition
Surgical laminar airflow unitAn electrically-powered device designed to filter air [usually through a high-efficiency particulate air (HEPA) filter] in surgical theatres by producing a directed, non-turbulent flow of clean air to provide an area free of contaminants and reduce the risk of patient infection. It may be mobile (on wheels) or fixed [e.g., to the ceiling], and provides a curtain of fast moving air that helps to delineate the sterile field; some types allow connection of a hose with a nozzle designed to be adhered to the patient to direct the filtered air across the surgical site. An operating light or light system may be mounted to this unit.

Contacts#

Phone, Email table
PhoneEmail
888-978-7087sales@aerobiotix.com

Regulatory Flags#

DUNS number
140411084
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00852348007155AerobiotixAeroCure VAC+2023-06-30
00852348007179AerobiotixAeroCure VAC+ ULPA Filter Cartridge2023-06-30
00852348007186AerobiotixAeroCure VAC+ Intake Arm2023-06-30
00852348007193AerobiotixAeroCure VAC+ Foot Pedal2023-06-30
00852348007308IlluviaExtended Use RFID Cartridge2023-06-02
00852348007988IlluviaHUAIRS+2023-03-01
00852348007438AerobiotixAeroCure Vac Hose XL2022-11-15
00852348007582AerobiotixULPA Carbon F Filter2022-11-15
00852348007773AerobiotixAeroCure-MD2022-02-04
00852348007452AerobiotixAeroCure Vac Sterile Filter Drape2022-01-03
00852348007322IlluviaUVC Germicidal Lamp2021-12-03
00852348007568AerobiotixAeroCure Vac HEPA Filter Assembly2021-12-03
00852348007445AerobiotixAeroCure Vac Filter Drape2021-10-01
00852348007551AerobiotixAeroCure Vac2021-09-03
00852348007292IlluviaCartridge Assembly RFID2021-09-01
00852348007889IlluviaSENSE2021-09-01
00852348007117IlluviaCartridge, PL12019-02-14
00852348007223IlluviaCartridge, PL 22019-02-14
00852348007995IlluviaHUAIRS-MD2019-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852348007155AerobiotixAEROBIOTIX USA LLCFZH2023-06-30
00852348007179AerobiotixAEROBIOTIX USA LLCFZH2023-06-30
00852348007186AerobiotixAEROBIOTIX USA LLCFZH2023-06-30
00852348007193AerobiotixAEROBIOTIX USA LLCFZH2023-06-30
00852348007308IlluviaAEROBIOTIX USA LLCFZH2023-06-02
00852348007988IlluviaAEROBIOTIX USA LLCFZH2023-03-01
00852348007322IlluviaAEROBIOTIX USA LLCFZH2021-12-03
00852348007292IlluviaAEROBIOTIX USA LLCFZH2021-09-01
00852348007889IlluviaAEROBIOTIX USA LLCFZH2021-09-01
00841132124277ACLORTHOPEDIATRICS CORP.FZH2021-07-06
06973495370061JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370078JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370085JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
16973495370006JUD careShenzhen Juding Medical Co., Ltd.FZH2021-06-25
06973495370023JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
06973495370030JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
06973495370047JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
26973495370003JUD careShenzhen Juding Medical Co., Ltd.FZH2021-03-08
00852348007117IlluviaAEROBIOTIX USA LLCFZH2019-02-14
00852348007223IlluviaAEROBIOTIX USA LLCFZH2019-02-14
00852348007995IlluviaAEROBIOTIX USA LLCFZH2019-02-14