Insighters 868.554

GUDID 06970831726179

Shenzhen Insighters Medical Technology Co., Ltd.

Video intubation laryngoscope handle/monitor

• Primary Device ID: 06970831726179
• NIH Device Record Key: 11d4b862-b5e1-4a8e-8f38-7457e22f99aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insighters
• Version Model Number: Handle (iS3)
• Catalog Number: 868.554
• Company DUNS: 551096917
• Company Name: Shenzhen Insighters Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970831726179 [Primary]

FDA Product Code

• CCW: Laryngoscope, Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-17
• Device Publish Date: 2023-04-08

On-Brand Devices [Insighters]

• 06970831720016: iS3-R
• 06970831726032: iS6-L Handle
• 06970831726025: 3.5-inch Host
• 06970831723239: insight iS6
• 06970831726087: Trolley iS-TC2
• 06970831726070: Trolley iS-TC1
• 06970831723260: iS-PF2
• 06970831726162: 3.5 inch Host (iS3)
• 06970831726186: Power Adapter
• 06970831726179: Handle (iS3)
• 06970831726063: Power Adapter
• 06970831726056: Connection Cable
• 06970831726049: Wireless Module
• 06970831723253: iS-PF1