FDA.reportPublic FDA data

Airtraq

Primary DI
40693602610616
Brand
Airtraq
Company
Prodol Meditec Limited
Model
A-061
Device description
Airtraq SP Video Laryngoscope Unchanneled
Published
2024-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10693602610615PackageGS16In Commercial Distribution
30693602610619PackageGS130In Commercial Distribution
40693602610616PackageGS12In Commercial Distribution
80693602610614PackageGS130In Commercial Distribution
00693602610618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1069360261061510693602610615
3069360261061930693602610619
4069360261061640693602610616
8069360261061480693602610614
00693602610618006936026106186936026106180693602610618

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421368931
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
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
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09
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00810055251360Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251377Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251384Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251391Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251414Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251421Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251445Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251452Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251469Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251476Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251483Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251490Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251506Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257744Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257768Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257782Surgical DesignSurgical Design, Inc.CCW2026-06-09
00879123009340GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
00879123009357GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
08436031030112AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030211AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030310AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030419AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030518AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030617AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033908AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01