VivaSight DL AS Set Includes

Basic Information

• Brand Name: VivaSight DL AS Set Includes
• Primary DI: 07290013745705
• Version / Model: DLVT35LAS
• Catalog Number: DLVT35LAS
• Company Name: E.T. VIEW LTD
• Labeler DUNS: 534096359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: cfd4b216-9bdf-41b9-ac31-d922179efe2b

Device Description

Visualized double lumen endobronchial tube set. The set includes DLVT35 tube +adapter cable, two suction catheter 8RF and two mully suction catheter 10RF+Finger tip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	868.5740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31328	Endobronchial tube	A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290013745709	GS1	Carton	2	In Commercial Distribution
Package	17290013745702	GS1	Carton	5	In Commercial Distribution
Primary	07290013745705	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123853	000