FDA.reportPublic FDA data

Hemoflow™

Primary DI
10840861100023
Brand
Hemoflow™
Company
Fresenius Medical Care Holdings, Inc.
Model
0520161A
Device description
F4 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.7 m2 / ETO / Low Volume / Single Use / 42 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
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190459000
K874872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190459000Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC2019-08-23FJI
K874872000FRESENIUS HEMOFLOW F3, F4, F5, F7Seratronics, Inc.1988-02-19FJI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861100023PackageGS115In Commercial Distribution
00840861100026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110002310840861100023
00840861100026008408611000268408611000260840861100026

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 Area0.7Square meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius27 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
958291411
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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