FDA.reportPublic FDA data

Aegis Air Filtration System Unit Filtration Cover

Primary DI
00872320005702
Brand
Aegis Air Filtration System Unit Filtration Cover
Company
CAO GROUP, INC.
Model
005-00088
Device description
Unit filtration cover for the Aegis Air Filtration Unit - A Portable air filtration station to remove particulates and contaminants from the air within an enclosed room or space.
Published
2020-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00872320005702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320005702008723200057028723200057020872320005702

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

Regulatory Flags#

DUNS number
102422578
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00872320005825LEAP Cavity Cleansing Solution006-002722026-04-10
00872320006440Picasso Pro Diode Laser002-004602026-04-10
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00872320006891Picasso Pro Disposable Therapy Tip, Straight052212026-04-10
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00872320006761Monet + Curing Laser001-001232026-02-10
00872320004477Ultimate Contour Mini005-000362019-09-06
00872320003364Pilot Diode Laser 600um Tip030932016-11-10
00872320003418Pilot Straight Tip006682016-11-10
00872320003425Pilot 60° Tip006692016-11-10
00872320003456Pilot Diode Laser030922016-11-10
00872320006457Acuity Direct X-Ray Photon Detection005-001232024-02-19
00872320006464Acuity Direct X-Ray Photon Detection005-002142024-02-19
00872320000127BlissBond Intro Kit006-00044006-000442016-11-10

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