FDA.reportPublic FDA data

Illuvia

Primary DI
00852348007117
Brand
Illuvia
Company
AEROBIOTIX, INC.
Model
Cartridge, PL1
Device description
Air purification filter
Published
2019-02-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00852348007117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852348007117008523480071178523480071170852348007117

GMDN Terms#

Term, Definition table
TermDefinition
Surgical laminar airflow unitAn air-handling unit designed for use in surgical theatres to produce a directed, non-turbulent flow of clean air and thereby provide an area free of contaminants to reduce the possibility of infection to the patient. The air is filtered, usually through a high-efficiency particulate air (HEPA) filter, to remove particulate matter and microorganisms. The unit is fixed, often built-in, typically to the ceiling, and provides a curtain of fast moving air around the perimeter of the area which will form an outer wall and help delineate between the "sterile" and "non-sterile" operation area. An operating light or light system may be mounted to this unit or within the specified area.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
046659903
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852348007452AerobiotixAeroCure Vac Sterile Filter Drape2022-01-03
00852348007445AerobiotixAeroCure Vac Filter Drape2021-10-01
00852348007155AerobiotixAeroCure VAC+2023-06-30
00852348007179AerobiotixAeroCure VAC+ ULPA Filter Cartridge 2023-06-30
00852348007186AerobiotixAeroCure VAC+ Intake Arm2023-06-30
00852348007193AerobiotixAeroCure VAC+ Foot Pedal2023-06-30
00852348007308IlluviaExtended Use RFID Cartridge2023-06-02
00852348007988IlluviaHUAIRS+2023-03-01
00852348007292IlluviaCartridge Assembly RFID2021-09-01
00852348007223IlluviaCartridge, PL 22019-02-14
00852348007438AerobiotixAeroCure Vac Hose XL2022-11-15
00852348007582AerobiotixULPA Carbon F Filter 2022-11-15
00852348007773AerobiotixAeroCure-MD2022-02-04
00852348007568AerobiotixAeroCure Vac HEPA Filter Assembly2021-12-03
00852348007322IlluviaUVC Germicidal Lamp2021-12-03
00852348007896IlluviaIlluvia HEPA Filter2021-12-03
00852348007551AerobiotixAeroCure Vac2021-09-03
00852348007889IlluviaSENSE2021-09-01
00852348007995IlluviaHUAIRS-MD2019-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852348007155AerobiotixAEROBIOTIX, INC.FZH2023-06-30
00852348007179AerobiotixAEROBIOTIX, INC.FZH2023-06-30
00852348007186AerobiotixAEROBIOTIX, INC.FZH2023-06-30
00852348007193AerobiotixAEROBIOTIX, INC.FZH2023-06-30
00852348007308IlluviaAEROBIOTIX, INC.FZH2023-06-02
00852348007988IlluviaAEROBIOTIX, INC.FZH2023-03-01
00852348007322IlluviaAEROBIOTIX, INC.FZH2021-12-03
00852348007896IlluviaAEROBIOTIX, INC.FZH2021-12-03
00852348007292IlluviaAEROBIOTIX, INC.FZH2021-09-01
00852348007889IlluviaAEROBIOTIX, INC.FZH2021-09-01
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
00852348007223IlluviaAEROBIOTIX, INC.FZH2019-02-14
00852348007995IlluviaAEROBIOTIX, INC.FZH2019-02-14