Insighters

Basic Information

• Brand Name: Insighters
• Primary DI: 06970831723253
• Version / Model: iS-PF1
• 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: 2023-01-06
• Public Version: 2
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 3b88ed66-eb37-4205-b6c2-ad284b4c1ffa

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
OUG	Medical Device Data System	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56654	Endoscopic video image display unit	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970831723253	GS1