VivaSight™ 2 DLT Kit 37 Fr - LEFT

Basic Information

• Brand Name: VivaSight™ 2 DLT Kit 37 Fr - LEFT
• Primary DI: 05707480145737
• Version / Model: 412371000
• Catalog Number: 412371000
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-25
• Public Version: 1
• Public Version Date: 2021-07-05
• Public Version Status: New
• Public Device Record Key: b9d9fde8-b817-4dfb-b3bc-337cbe93e6b2

Device Description

VivaSight 2 DLT Kit 37 Fr - LEFT

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: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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	05707480145744	GS1		5	In Commercial Distribution
Primary	05707480145737	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Adult
Lumen/Inner Diameter	4.6	Millimeter
Outer Diameter	11	Millimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius