AincA®

Basic Information

• Brand Name: AincA®
• Primary DI: B005GL350LED0
• Version / Model: GL-350-LED
• Catalog Number: GL-350-LED
• Company Name: ANESTHESIA ASSOCIATES, INC.
• Labeler DUNS: 002065670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 1
• Public Version Date: 2021-04-08
• Public Version Status: New
• Public Device Record Key: a0ecf2ea-7534-46eb-a1a5-895a71c467ea

Device Description

Handle, Laryngoscope, GreenLine F/O, LED Bulb Assembly, Standard Size (29mm x 160mm) (Req 2 C)

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: 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: No
• 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
15076	Rigid intubation laryngoscope, reusable	A hand-held device intended to be used by anaesthesia/emergency service personnel 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 prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B005GL350LED0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]