FDA.reportPublic FDA data

Aerobiotix

Primary DI
00852348007551
Brand
Aerobiotix
Company
AEROBIOTIX, INC.
Model
AeroCure Vac
Device description
Air purification machine
Published
2021-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRAPurifier, Air, Ultraviolet, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRAPurifier, Air, Ultraviolet, MedicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203189000AEROCURE-MDAerobiotix, Inc.2021-01-21FRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852348007551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852348007551008523480075518523480075510852348007551

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
046659903
Device count
1
Serial number
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
00852348007117IlluviaCartridge, PL12019-02-14
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
00852348007889IlluviaSENSE2021-09-01
00852348007995IlluviaHUAIRS-MD2019-02-14

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Primary DI, Brand, Company table
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