Insighters

Basic Information

• Brand Name: Insighters
• Primary DI: 06970831723383
• Version / Model: 9Fr
• 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: 2026-04-10
• Public Version: 1
• Public Version Date: 2026-04-20
• Public Version Status: New
• Public Device Record Key: b9d869ef-53ed-4c3b-8c71-ba4cfb13eccf

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
17827	Bronchial balloon catheter	A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970831723383	GS1

Premarket Submissions

Submission Number	Supplement Number
K232580	000