FDA.reportPublic FDA data

Aerobiotix

Primary DI
00852348007452
Brand
Aerobiotix
Company
AEROBIOTIX USA LLC
Model
AeroCure Vac Sterile Filter Drape
Device description
Sterile air purification pre-filter
Published
2022-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852348007452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852348007452008523480074528523480074520852348007452

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

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
00852348007322IlluviaUVC Germicidal Lamp2021-12-03
00852348007568AerobiotixAeroCure Vac HEPA Filter Assembly2021-12-03
00852348007896IlluviaIlluvia HEPA Filter2021-12-03
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
00380657530021ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
00380659983313ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
B376KB100DAB0Drape KB100 SeriesKent Imaging IncPUI2026-07-21
10198956353954CARDINAL HEALTHCardinal Health 200, LLCPUI2026-07-20
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)MolecuLight IncPUI2026-07-08
00628110259578MolecuLightDX DarkDrape Eco ClipMolecuLight IncPUI2026-07-08
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04