Airtraq

Basic Information

• Brand Name: Airtraq
• Primary DI: 08436031035117
• Version / Model: A-511
• Company Name: PRODOL MEDITEC, SA
• Labeler DUNS: 541001090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-01
• Public Version: 1
• Public Version Date: 2023-08-09
• Public Version Status: New
• Public Device Record Key: a1cac70a-ac65-4e2a-8815-b8ecbacf7c59

Device Description

Airtraq Avant Regular Blade

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCW	Laryngoscope, Rigid	Anesthesiology	868.5540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64797	Video intubation laryngoscope blade/handle shell	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	68436031035119	GS1	Box	10	In Commercial Distribution
Primary	08436031035117	GS1
Package	58436031035112	GS1	Box	50	In Commercial Distribution