Insighters

Basic Information

• Brand Name: Insighters
• Primary DI: 06970831723888
• Version / Model: Visible Right type B 41Fr
• Company Name: Shenzhen Insighters Medical Technology Co., Ltd.
• Labeler DUNS: 551096917
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-14
• Public Version: 1
• Public Version Date: 2026-04-22
• Public Version Status: New
• Public Device Record Key: be1e0822-89c3-4f49-8e45-48f37dcfa5ce

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	868.5740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32158	Tracheobronchial suction/insufflation catheter, dual-lumen	A sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a dual-lumen tube which allows simultaneous suction and insufflation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970831723888	GS1

Premarket Submissions

Submission Number	Supplement Number
K232529	000