Deflux®

Basic Information

• Brand Name: Deflux®
• Primary DI: 00365649922039
• Version / Model: 1092203
• Company Name: SALIX PHARMACEUTICALS, LTD.
• Labeler DUNS: 793108036
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-31
• Public Version: 5
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: 9ed694b5-66f3-4c21-ab35-02ab802f841c

Device Description

Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.

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
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60700	Urinary tract reconstructive material, microbe-derived	A sterile, bioabsorbable material intended for submucosal injection in the urinary tract (urethra, urinary bladder, and/or distal ureter) to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of stress urinary incontinence (SUI) and/or vesicoureteral reflux (VUR); it does not include a local anaesthetic agent. It is in the form of a gel of biosynthesized dextranomer microspheres and hyaluronic acid (HA) derived from bacteria. The material is typically preloaded in a disposable syringe.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00365649922039	GS1
Package	10365649922036	GS1	Transport Box	96	In Commercial Distribution

Customer Contacts

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