ANKOR endobronchial tube

GUDID 08800115141931

INSUNG MEDICAL Co., Ltd..

Endobronchial tube

• Primary Device ID: 08800115141931
• NIH Device Record Key: 9854b907-5e11-4ac9-ae31-4e9ea1046ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANKOR endobronchial tube
• Version Model Number: ABC33R
• 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	08800115141931 [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 [ANKOR endobronchial tube]

• 08800115141993: ABC39R
• 08800115141986: ABC39L
• 08800115141979: ABC37R
• 08800115141962: ABC37L
• 08800115141955: ABC35R
• 08800115141948: ABC35L
• 08800115141931: ABC33R
• 08800115141924: ABC33L