FDA.reportPublic FDA data

Airtraq

Primary DI
68436031035218
Brand
Airtraq
Company
PRODOL MEDITEC, SA
Model
A-521
Device description
Airtraq Avant Small Blade
Published
2023-08-01
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
58436031035211PackageGS150In Commercial Distribution
68436031035218PackageGS110In Commercial Distribution
08436031035216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5843603103521158436031035211
6843603103521868436031035218
08436031035216084360310352168436031035216

GMDN Terms#

Term, Definition table
TermDefinition
Video intubation laryngoscope blade/handle shellA non-electronic, hand-held component of a video intubation laryngoscope intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube. It is designed as a user-assembled casing intended to accept a digital camera with light source (not included) at the distal blade end, and a smartphone (not included) within the handle, to provide video imaging. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541001090
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
08436031033908AirtraqA-3902023-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
G14140464270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-05
G1414046400Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464290Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046430Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464370Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464380Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G141404643850Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464390Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046440Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464470Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464480Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464490Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466170Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03