Airtraq

Basic Information

• Brand Name: Airtraq
• Primary DI: 08436031033908
• Version / Model: A-390
• 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: ee654963-4549-4e29-9659-f2c5184483d0

Device Description

Airtraq A-390 WiFi Camera

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
64798	Video intubation laryngoscope imaging system	An assembly of video-imaging devices intended to be user-installed in a video intubation laryngoscope blade/handle shell (not included) to make functional a video intubation laryngoscope, enabling video imaging of the trachea during insertion of an endotracheal (ET) tube. It includes an electronic camera with integrated light, designed to be installed at the distal end of the blade, with dedicated software installed in a smartphone designed to be mounted on the handle; the smartphone provides power to, and receives image data from, the integrated camera. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	78436031033907	GS1	Box	5	In Commercial Distribution
Primary	08436031033908	GS1