POLYFLUX

Basic Information

• Brand Name: POLYFLUX
• Primary DI: 07332414047108
• Version / Model: 10LR
• Catalog Number: 104311
• Company Name: Gambro Dialysatoren GmbH
• Labeler DUNS: 316150549
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-12
• Public Version: 6
• Public Version Date: 2023-07-27
• Public Version Status: Update
• Public Device Record Key: 24ea892e-f3e2-49ef-9fb2-6240d9ebc8cf
• Distribution End Date: 2021-04-09

Device Description

The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse on the same patient

Device Characteristics

• Single Use: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSF	HEMODIALYZER, RE-USE, HIGH FLUX	Gastroenterology, Urology	876.5860	2
KDI	Dialyzer, high permeability with or without sealed dialysate system	Gastroenterology, Urology	876.5860	2
FJI	DIALYZER, CAPILLARY, HOLLOW FIBER	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47071	Hollow-fibre haemodialysis dialyser, reusable	A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-patient, reusable device after high-level disinfection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37332414047109	GS1	CASE	16	Not in Commercial Distribution	2021-04-09
Primary	07332414047108	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043342	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 30 Degrees Celsius