Archimedes Dilation Balloon

Basic Information

• Brand Name: Archimedes Dilation Balloon
• Primary DI: 00856571007074
• Version / Model: 10008
• Catalog Number: 10008
• 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: 1357f10b-a7e8-4c9f-a270-bedd2c841ce6

Device Description

A sterile single use flexible tube with a balloon at or near the distal tip that is inserted through the bronchoscope or sheath and used to dilate the target lung tissue of the bronchial tree.

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
17827	Bronchial balloon catheter	A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856571007074	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131234	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.9	Millimeter

Storage Conditions

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