VivaSight DL AS Set Includes DLVT37LAS

GUDID 27290013745716

Visualized double lumen endobronchial tube set. The set includes DLVT37 tube + adapter cable, two suction catheter 8RF and two mully suction catheter

E.T. VIEW LTD

Endobronchial tube

• Primary Device ID: 27290013745716
• NIH Device Record Key: bb52d8bd-9799-48d8-865b-33dabe1792ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaSight DL AS Set Includes
• Version Model Number: DLVT37LAS
• Catalog Number: DLVT37LAS
• 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: true
• 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: +972-722607060
• Email: medical@ETView.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290013745712 [Primary]
GS1	17290013745719 [Package]; Contains: 07290013745712; Package: Carton [5 Units]; In Commercial Distribution
GS1	27290013745716 [Package]; Contains: 17290013745719; Package: Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123853

FDA Product Code

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

Sterilization

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

[27290013745716]

Ethylene Oxide

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 DL AS Set Includes]

• 27290013745730: Visualized double lumen endobronchial tube set. The set includes DLVT41 tube + adapter cable, tw
• 27290013745723: Visualized double lumen endobronchial tube set. The set includes DLVT39 tube +adapter cable, two
• 27290013745716: Visualized double lumen endobronchial tube set. The set includes DLVT37 tube + adapter cable, tw
• 27290013745709: Visualized double lumen endobronchial tube set. The set includes DLVT35 tube +adapter cable, tw