Human-broncho endobronchial tube

GUDID 08800115141825

INSUNG MEDICAL Co., Ltd..

Endobronchial tube

• Primary Device ID: 08800115141825
• NIH Device Record Key: be0aaa2b-f30a-43db-add4-2e2dba526d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Human-broncho endobronchial tube
• Version Model Number: HBC35L
• Company DUNS: 687938530
• Company Name: INSUNG MEDICAL Co., Ltd..
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800115141825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200968

FDA Product Code

• CBI: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-07
• Device Publish Date: 2025-04-29

On-Brand Devices [Human-broncho endobronchial tube]

• 08800115141870: HBC39R
• 08800115141863: HBC39L
• 08800115141856: HBC37R
• 08800115141849: HBC37L
• 08800115141832: HBC35R
• 08800115141825: HBC35L
• 08800115141818: HBC33R
• 08800115141801: HBC33L