LungPoint VBN System, V3.2 30005

GUDID 00856571007173

LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.

BRONCUS MEDICAL INC.

Virtual bronchoscopic navigation PACS software

• Primary Device ID: 00856571007173
• NIH Device Record Key: bb61db56-74ca-45e1-a440-f39abf44ded8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LungPoint VBN System, V3.2
• Version Model Number: 30005
• Catalog Number: 30005
• Company DUNS: 078684808
• Company Name: BRONCUS MEDICAL INC.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 650-428-1600
• Email: CustomerSupport@Broncus.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856571007173 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2017-06-27

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