Archimedes Sheath 10007

GUDID 00856571007067

A sterile single use flexible tube that provides a working channel during a bronchoscopic procedure through which other devices may be introduced to the targeted area within the respiratory organs. The sheath is advanced through the working channel of a bronchoscope and allows for the repeated placement of endoscopic devices to a specified lesion(s) during a procedure.

BRONCUS MEDICAL INC.

Bronchoscopic catheter

• Primary Device ID: 00856571007067
• NIH Device Record Key: 76631369-cfd9-47fb-9f80-5ed35dc24e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Archimedes Sheath
• Version Model Number: 10007
• Catalog Number: 10007
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Outer Diameter: 2.6 Millimeter
• Outer Diameter: 2.6 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856571007067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131234

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-22
• 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: 2019-05-23 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