Archimedes Access Kit 10009

GUDID 00856571007029

A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.

BRONCUS MEDICAL INC.

Lung biopsy procedure kit

• Primary Device ID: 00856571007029
• NIH Device Record Key: 8fbd0541-50a6-4c3a-be63-165a78358a0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Archimedes Access Kit
• Version Model Number: 10009
• Catalog Number: 10009
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856571007029 [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

On-Brand Devices [Archimedes Access Kit]

• 00856571007029: A collection of sterile devices designed to access and perform a biopsy sample during a lung bio
• 00856571007296: A collection of sterile devices designed to access and perform a biopsy sample during a lung bio