FDA.reportPublic FDA data

Airtraq

Primary DI
08436031030112
Brand
Airtraq
Company
PRODOL MEDITEC, SA
Model
A-011
Device description
Airtraq SP Regular
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
38436031030113PackageGS130In Commercial Distribution
48436031030110PackageGS12In Commercial Distribution
08436031030112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3843603103011338436031030113
4843603103011048436031030110
08436031030112084360310301128436031030112

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
541001090
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
78436031033921AirtraqA-390-KIT2023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971355350147BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350154BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350161BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
25056094503100PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503117PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503124PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503131PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503148PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503155PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503162PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503179PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503186PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503193PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503209PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503216PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503223PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503230PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503254PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503261PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31