Archimedes Access Kit

Basic Information

• Brand Name: Archimedes Access Kit
• Primary DI: 00856571007029
• Version / Model: 10009
• Catalog Number: 10009
• Company Name: BRONCUS MEDICAL INC.
• Labeler DUNS: 078684808
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-27
• Public Version: 4
• Public Version Date: 2019-02-22
• Public Version Status: Update
• Public Device Record Key: 8fbd0541-50a6-4c3a-be63-165a78358a0f

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38562	Lung biopsy procedure kit	A collection of sterile devices designed to perform a histologic specimen aspiration during a percutaneous lung biopsy. It typically includes a biopsy needle and other supplies to perform this procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856571007029	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131234	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature