SILBRONCHO (RIGHT LUNG) 1203637

GUDID 04544050083942

SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lung ventilation in thoracic surgery, lung resection, VAT

FUJI SYSTEMS CORPORATION

Endobronchial tube

• Primary Device ID: 04544050083942
• NIH Device Record Key: 95e51c33-4ece-426a-ad5c-7493ddd29c9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILBRONCHO (RIGHT LUNG)
• Version Model Number: #37
• Catalog Number: 1203637
• Company DUNS: 715919973
• Company Name: FUJI SYSTEMS CORPORATION
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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	04544050083942 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [SILBRONCHO (RIGHT LUNG)]

• 04544050083959: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
• 04544050083942: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
• 04544050083935: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
• 04544050083928: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
• 14544050124000: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
• 14544050123997: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
• 14544050123980: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun
• 14544050123973: SILBRONCHO Tube is intended for use in airway management of surgical patients to perform one-lun