UNIBLOCKER 1203104

GUDID 04544050123914

UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lung resection, VATS, lobectomy, etc.

FUJI SYSTEMS CORPORATION

Bronchial balloon catheter

• Primary Device ID: 04544050123914
• NIH Device Record Key: b6138171-ece7-4806-ba35-765568a7e732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIBLOCKER
• Version Model Number: 5.0FR
• Catalog Number: 1203104
• 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	04544050080965 [Previous]
GS1	04544050123914 [Primary]
GS1	14544050123911 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894337

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: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [UNIBLOCKER]

• 04544050080965: UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right
• 04544050063715: UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right
• 04544050123914: UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right
• 14544050123928: UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right