VivaSight AS Pack Set include TVEB80110AS

GUDID 17290013745795

Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.

E.T. VIEW LTD

Bronchial balloon catheter

• Primary Device ID: 17290013745795
• NIH Device Record Key: 4af48a73-41a5-4996-985b-6396a2e2aab4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaSight AS Pack Set include
• Version Model Number: TVEB80110AS
• Catalog Number: TVEB80110AS
• Company DUNS: 534096359
• Company Name: E.T. VIEW LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97272607060
• Email: medical@ETView.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290013745798 [Primary]
GS1	17290013745795 [Package]; Contains: 07290013745798; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120334

FDA Product Code

• BTR: Tube, Tracheal (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: 2018-02-21

On-Brand Devices [VivaSight AS Pack Set include]

• 17290013745795: Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.
• 17290013745788: Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker.
• 17290013745771: Oral/Nasal Cuffed visualization Endotracheal tube+Endobronchial blocker