VivaSight Pack TVEB80110

GUDID 07290013745569

Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.

E.T. VIEW LTD

Bronchial balloon catheter

• Primary Device ID: 07290013745569
• NIH Device Record Key: 473b0078-458d-4bf4-9655-7fc0ed2900e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaSight Pack
• Version Model Number: TVEB80110
• Catalog Number: TVEB80110
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290013745569 [Primary]
GS1	17290013745566 [Package]; 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: 2016-09-24

On-Brand Devices [VivaSight Pack]

• 07290013745569: Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.
• 07290013745552: Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.
• 17290013745542: A kit wich contains one sterile packed VivaSight SL (Oral/Nasal Cuffed visualization Endotrachea