LungPoint Planning System, v3.2 30009

GUDID 00856571007128

LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.

BRONCUS MEDICAL INC.

Virtual bronchoscopic navigation PACS software

• Primary Device ID: 00856571007128
• NIH Device Record Key: 14e2dd43-bd51-4dc0-a075-3d1a9fe82ff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LungPoint Planning System, v3.2
• Version Model Number: 30009
• Catalog Number: 30009
• 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	00856571007128 [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

Devices Manufactured by BRONCUS MEDICAL INC.

• 00856571007296 - Archimedes Access Kit: 2021-10-12 A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
• 00856571007241 - Empower RF Catheter: 2019-11-11 The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target
• 00856571007036 - Archimedes System: 2019-05-23 Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedu
• 00856571007104 - Archimedes Planning System: 2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
• 00856571007128 - LungPoint Planning System, v3.2: 2019-05-23LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.
• 00856571007128 - LungPoint Planning System, v3.2: 2019-05-23 LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
• 00856571007173 - LungPoint VBN System, V3.2: 2019-05-23 LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung.
• 00856571007227 - Archimedes Access Key: 2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning
• 00856571007258 - Archimedes Access Key, 10-pack: 2019-05-23 Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning