Optiflux®

GUDID 10840861100146

F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 87 mL

Fresenius Medical Care Holdings, Inc.

Hollow-fibre haemodialysis dialyser, single-use
Primary Device ID10840861100146
NIH Device Record Keyb9b2cbb0-3bd4-4a4d-8e0e-27efc844b278
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiflux®
Version Model Number0500316E
Company DUNS958291411
Company NameFresenius Medical Care Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx
Phone+1(800)323-5188
Emailxx@xx.xx

Device Dimensions

Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter
Area/Surface Area1.5 Square meter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840861100149 [Primary]
GS110840861100146 [Package]
Contains: 00840861100149
Package: [12 Units]
In Commercial Distribution

FDA Product Code

FJIDIALYZER, CAPILLARY, HOLLOW FIBER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-21
Device Publish Date2015-09-24

On-Brand Devices [Optiflux®]

10840861100177F250NR Optiflux Dialyzer / High Flux / Polysulfone / 2.5 m2 / Ebeam / Single Use / 142 mL
10840861100160F200NR Optiflux Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 113 mL
10840861100153F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / Ebeam / Single Use / 102 mL
10840861100146F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 87 mL
10840861100139F200NR Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Single Use / 113 mL
10840861100122F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Single Use / 105 mL
10840861100115F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / ETO / Single Use / 84 mL
10840861100108F200A Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Multiple Use / 113 mL
10840861100092F180A Optiflux Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 99 mL
10840861100085F18NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.8 m2 / Ebeam / Single Use / 103 mL
10840861100078F16NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 84 mL

Trademark Results [Optiflux]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTIFLUX
OPTIFLUX
88953944 not registered Live/Pending
TRS Group, Inc.
2020-06-08
OPTIFLUX
OPTIFLUX
79002262 3117288 Dead/Cancelled
KROHNE Meßtechnik GmbH & Co. KG
2004-03-04
OPTIFLUX
OPTIFLUX
76228793 2519989 Live/Registered
Fresenius USA Marketing, Inc.
2001-03-22
OPTIFLUX
OPTIFLUX
74420318 1884262 Dead/Cancelled
NCSRT, INC.
1993-08-04
OPTIFLUX
OPTIFLUX
73077279 1053141 Dead/Expired
GROBET FILE COMPANY OF AMERICA, INC.
1976-02-17

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