POLYFLUX

Basic Information

• Brand Name: POLYFLUX
• Primary DI: 07332414036140
• Version / Model: 24R
• Catalog Number: 104324
• 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: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: 5092af02-da21-44da-a799-11f1a96df9c9
• Distribution End Date: 2021-04-09

Device Description

Polyflux R is intended for use in hemodialysis for the treatment of chronic and acute renal failure Polyflux R 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
FJI	DIALYZER, CAPILLARY, HOLLOW FIBER	Gastroenterology, Urology	876.5820	2
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

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	37332414036141	GS1	CASE	16	Not in Commercial Distribution	2021-04-09
Primary	07332414036140	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