DISPOSABLE BALLOON CATHETER

Basic Information

• Brand Name: DISPOSABLE BALLOON CATHETER
• Primary DI: 04953170454264
• Version / Model: B7-2LA
• Catalog Number: N6215240
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-19
• Public Version: 1
• Public Version Date: 2025-11-27
• Public Version Status: New
• Public Device Record Key: 0ba2a3eb-8042-4fb6-b7c0-546325eec08f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65545	Gastrointestinal/tracheobronchial balloon catheter	A multi-purpose flexible tube with an inflatable balloon at the distal end designed to be introduced into either the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) or tracheobronchial tree (i.e., capable of both) for the injection/irrigation of fluids (e.g., contrast medium), removal of foreign bodies (e.g., biliary stones, food), and control of bleeding. It typically has more than one lumen and port for the separate introduction of fluids and air, and is introduced via a flexible endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14953170454261	GS1		1	In Commercial Distribution
Primary	04953170454264	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K250409	000