SILBRONCHO (LEFT LUNG) 1203533

GUDID 04544050123938

SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VATS, lobectomy and etc.

FUJI SYSTEMS CORPORATION

Endobronchial tube

• Primary Device ID: 04544050123938
• NIH Device Record Key: 3ca1337f-7fdb-4689-ba54-96e1db26954d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILBRONCHO (LEFT LUNG)
• Version Model Number: #33
• Catalog Number: 1203533
• Company DUNS: 715919973
• Company Name: FUJI SYSTEMS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04544050061148 [Previous]
GS1	04544050123938 [Primary]
GS1	14544050123935 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051522

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: 2023-09-13
• Device Publish Date: 2023-09-05

Devices Manufactured by FUJI SYSTEMS CORPORATION

• 14544050123812 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123836 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123843 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123850 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123867 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123874 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123881 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve
• 14544050123898 - UNIVENT TUBE (TCB TYPE): 2024-02-08 ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is indicated for use in airway management of surgical patients to perform one-lung ve