FDA.reportPublic FDA data

Airtraq

Primary DI
08436031033908
Brand
Airtraq
Company
PRODOL MEDITEC, SA
Model
A-390
Device description
Airtraq A-390 WiFi Camera
Published
2023-08-01
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
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
78436031033907PackageGS15In Commercial Distribution
08436031033908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7843603103390778436031033907
08436031033908084360310339088436031033908

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope imaging systemAn assembly of video-imaging devices intended to be user-installed in a video intubation laryngoscope blade/handle shell (not included) to make functional a video intubation laryngoscope, enabling video imaging of the trachea during insertion of an endotracheal (ET) tube. It includes an electronic camera with integrated light, designed to be installed at the distal end of the blade, with dedicated software installed in a smartphone designed to be mounted on the handle; the smartphone provides power to, and receives image data from, the integrated camera. This is a reusable device.

Regulatory Flags#

DUNS number
541001090
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436031030112AirtraqA-0112023-08-01
08436031030211AirtraqA-0212023-08-01
08436031030310AirtraqA-0312023-08-01
08436031030419AirtraqA-0412023-08-01
08436031030518AirtraqA-0512023-08-01
08436031030617AirtraqA-0612023-08-01
08436031033922AirtraqA-390-KIT2023-08-01
08436031035018AirtraqA-5012023-08-01
08436031035117AirtraqA-5112023-08-01
08436031035216AirtraqA-5212023-08-01
08436031035902AirtraqA-5902023-08-01
48436031030110AirtraqA-0112023-08-01
48436031030219AirtraqA-0212023-08-01
48436031030318AirtraqA-0312023-08-01
48436031030417AirtraqA-0412023-08-01
48436031030516AirtraqA-0512023-08-01
48436031030615AirtraqA-0612023-08-01
08436031030716AirtraqA-0712023-08-01
78436031033907AirtraqA-3902023-08-01
78436031033921AirtraqA-390-KIT2023-08-01

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