Lumiflex

Basic Information

• Brand Name: Lumiflex
• Primary DI: 00724995244637
• Version / Model: 00715512
• Catalog Number: 00715512
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-03
• Public Version: 1
• Public Version Date: 2025-06-11
• Public Version Status: New
• Public Device Record Key: 68e72d8f-dceb-411d-98cd-a6c14f25066a

Device Description

LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm no wire is made of nylon and is a progressive stage balloon capable of three disctinct and progressively larger diameters via controlled radial expansion.

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: Yes
• 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
KNQ	Dilator, esophageal	Gastroenterology, Urology	876.5365	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45712	Gastrointestinal/biliary dilation balloon catheter, non-medicated	A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995244637	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K241888	000

Device Sizes

Type	Value	Unit	Text
Catheter Length	240	Centimeter
Balloon Length	5.5	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.