FDA.reportPublic FDA data

Airtraq

Primary DI
00693602613923
Brand
Airtraq
Company
Prodol Meditec Limited
Model
A-390-KIT
Device description
Airtraq Wi-Fi Camera Kit
Published
2024-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
70693602613922PackageGS15In Commercial Distribution
00693602613923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
7069360261392270693602613922
00693602613923006936026139236936026139230693602613923

GMDN Terms#

Term, Definition table
TermDefinition
Channelled video intubation laryngoscopeA hand-held device intended to enable clear view of the trachea via video imaging to facilitate positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation, passing the ET tube through an integrated ET tube channel guide without use of a stylet for positioning. It typically consists of a body with an ET tube channel, an anatomically-shaped blade, and integrated electronic illumination and a video camera at the distal end; images are transmitted to an off-the-shelf device (e.g., tablet, smartphone, computer). This is a single-use device.

Regulatory Flags#

DUNS number
421368931
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00693602610113AirtraqA-0112024-10-10
00693602610212AirtraqA-0212024-10-16
00693602610311AirtraqA-0312024-10-16
00693602610410AirtraqA-0412024-10-16
00693602610618AirtraqA-0612024-10-16
00693602610717AirtraqA-0712024-10-16
00693602616016AirtraqA6012025-11-06
00693602616023AirtraqA600B2025-11-06
00693602616009AirtraqA6002025-03-19
00693602613008AirtraqA3002025-03-19
00693602616092AirtraqA6092025-03-19
00693602616108AirtraqA6C02025-03-19
00693602616115AirtraqA6C12025-03-19
00693602616122AirtraqA6C22025-03-19
00693602616139AirtraqA6C32025-03-19
00693602616146AirtraqA6M12025-03-19
00693602616153AirtraqA6M22025-03-19
00693602616160AirtraqA6M32025-03-19
00693602616177AirtraqA6M42025-03-19
00693602616184AirtraqA6HA2025-03-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04053755213092MEDUVISION Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213108MEDUVISION Mac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213115MEDUVISION Mac 2 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213122MEDUVISION Mac 4 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
00842209139149NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139156NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139163NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139170NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139187NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139194NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139200NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
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00810055257614Surgical DesignSurgical Design, Inc.CCW2026-06-10
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00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09