VivaSight-EB EBB09700AS

GUDID 17290013745801

Endobronchial blocker

E.T. VIEW LTD

Bronchial balloon catheter

• Primary Device ID: 17290013745801
• NIH Device Record Key: c801d22d-66bb-4a26-8362-8e59b2e72898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaSight-EB
• Version Model Number: EBB09700AS
• Catalog Number: EBB09700AS
• Company DUNS: 534096359
• Company Name: E.T. VIEW 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +972722607060
• Email: medical@ETView.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290013745804 [Primary]
GS1	17290013745801 [Package]; Contains: 07290013745804; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120334

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-21

On-Brand Devices [VivaSight-EB]

• 17290013745801: Endobronchial blocker
• 07290013745514: Endobronchial blocker.