Optiflux® Ultra

Basic Information

• Brand Name: Optiflux® Ultra
• Primary DI: 00840861100200
• Version / Model: 0500419E
• Company Name: Fresenius Medical Care Holdings, Inc.
• Labeler DUNS: 958291411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2022-05-05
• Public Version Status: Update
• Public Device Record Key: 0e2570e0-e4b7-429a-a717-4ba4e70d8c3b
• Distribution End Date: 2015-09-24

Device Description

F190 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 105 mL

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
KDI	Dialyzer, high permeability with or without sealed dialysate system	Gastroenterology, Urology	876.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47072	Hollow-fibre haemodialysis dialyser, single-use	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-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10840861100207	GS1		12	Not in Commercial Distribution	2015-09-24
Primary	00840861100200	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	1.9	Square meter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius