FDA.reportPublic FDA data

Optiflux®

Primary DI
00840861100149
Brand
Optiflux®
Company
Fresenius Medical Care Holdings, Inc.
Model
0500316E
Device description
F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 87 mL
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJIDIALYZER, CAPILLARY, HOLLOW FIBER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJIDialyzer, Capillary, Hollow FiberGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861100146PackageGS112In Commercial Distribution
00840861100149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110014610840861100146
00840861100149008408611001498408611001490840861100149

GMDN Terms#

Term, Definition table
TermDefinition
Hollow-fibre haemodialysis dialyser, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area1.5Square meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius27 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-5188xx@xx.xx

Regulatory Flags#

DUNS number
958291411
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840861100774stay.safe®050-950032015-10-02
00840861101955NaturaLyte08-4112-208-4112-22015-10-02
10840861100542Fresenius04-9500-204-9500-22015-09-30
20840861100549Fresenius04-9500-204-9500-22015-09-30
008408611020822008T BlueStar Hemodialysis Machine1911242018-05-23
008408611020992008T BlueStar Hemodialysis Machine1911262018-05-23
008408611021052008T BlueStar Hemodialysis Machine1911282018-05-23
008408611021122008T BlueStar Hemodialysis Machine1911302018-05-23
00840861101122Crit-Line®CL100510012016-11-17
00840861101139Crit-Line®CL100410012016-11-17
00840861102068Liberty® Select Cycler1803432018-02-26
00840861102631FX CorAL 60 DialyzerF000092162024-02-23
00840861102655FX CorAL 100 DialyzerF000092182024-02-23
00840861102662FX CorAL 120 DialyzerF000092192024-02-23
00840861102679FX CorAL 600 DialyzerF000092202024-02-23
00840861102686FX CorAL 800 DialyzerF000092212024-02-23
00840861102693FX CorAL 1000 DialyzerF000092222024-02-23
10840861102638FX CorAL 60 DialyzerF000092162024-02-23
10840861102652FX CorAL 100 DialyzerF000092182024-02-23
10840861102669FX CorAL 120 DialyzerF000092192024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B144MPC40S0Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2022-08-04
B144MPC40S1Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2022-08-04
B144MPC401Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2019-09-04
B144MPC451Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2019-09-04
B144MPC50DV1Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2019-09-04
B144MPC50DVY1Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2019-09-04
B144MPC60B1Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2019-09-04
B144MPC60D1Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2019-09-04
B144MPC60DR1Molded Products, Inc.MOLDED PRODUCTS, INC.FJI2019-09-04
00858293006298Blood Port Caps Twist Lock ISOREPROCESSING PRODUCTS CORPORATIONFJI2019-08-27
00858293006304Blood Port Caps Twist Lock ISO BulkREPROCESSING PRODUCTS CORPORATIONFJI2019-08-27
00858293006311Blood Port Caps - E-ZGrip, Rigid, Twist LockREPROCESSING PRODUCTS CORPORATIONFJI2019-08-27
00858293006366Dialysate Port Cap - E-Z Grip® Twist Lock - RigidREPROCESSING PRODUCTS CORPORATIONFJI2019-08-27
10858293006295Blood Port Caps Twist Lock ISOREPROCESSING PRODUCTS CORPORATIONFJI2019-08-27
10858293006301Blood Port Caps Twist Lock ISO BulkREPROCESSING PRODUCTS CORPORATIONFJI2019-08-27
10858293006318Blood Port Caps - E-ZGrip, Rigid, Twist LockREPROCESSING PRODUCTS CORPORATIONFJI2019-08-27
10858293006363Dialysate Port Cap - E-Z Grip® Twist Lock - RigidREPROCESSING PRODUCTS CORPORATIONFJI2019-08-27
00858293006212"Dialysate Port Caps 1.5"""REPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
00858293006229"Dialysate Port Caps 1.5"" Bulk"REPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
00858293006236"Dialysate Port Cap 1"""REPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
00858293006243"Dialysate POrt Caps 1"" Bulk"REPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
00858293006250Blood Port CapsREPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
00858293006267Blood Port Caps BulkREPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
00858293006274Auto-Vent Port CapsREPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
10858293006219Dialysate Port Caps 1.5"REPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
10858293006226Dialysate Port Caps 1.5" BulkREPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
10858293006233Dialysate Port Cap 1"REPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
10858293006240Dialysate POrt Caps 1" BulkREPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
10858293006257Blood Port CapsREPROCESSING PRODUCTS CORPORATIONFJI2019-08-26
10858293006264Blood Port Caps BulkREPROCESSING PRODUCTS CORPORATIONFJI2019-08-26