FDA.reportPublic FDA data

Hemoflow™

Primary DI
00840861100057
Brand
Hemoflow™
Company
Fresenius Medical Care Holdings, Inc.
Model
0500136A
Device description
F60A Hemoflow Dialyzer / High Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSFHEMODIALYZER, RE-USE, HIGH FLUX

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSFHemodialyzer, Re-Use, High FluxGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861100054PackageGS112Not in Commercial Distribution
00840861100057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084086110005410840861100054
00840861100057008408611000578408611000570840861100057

GMDN Terms#

Term, Definition table
TermDefinition
Hollow-fibre haemodialysis dialyser, reusableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area1.3Square meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 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
07332414031770POLYFLUXGambro Dialysatoren GmbHMSF2015-10-12
07332414031787POLYFLUXGambro Dialysatoren GmbHMSF2015-10-12
07332414036140POLYFLUXGambro Dialysatoren GmbHMSF2015-10-12
07332414041465POLYFLUXGambro Dialysatoren GmbHMSF2015-10-12
07332414041472POLYFLUXGambro Dialysatoren GmbHMSF2015-10-12
07332414047108POLYFLUXGambro Dialysatoren GmbHMSF2015-10-12
37332414031771PolyfluxGambro Dialysatoren GmbHMSF2015-10-12
37332414036424PolyfluxGambro Dialysatoren GmbHMSF2015-10-12
37332414041473PolyfluxGambro Dialysatoren GmbHMSF2015-10-12
37332414047109PolyfluxGambro Dialysatoren GmbHMSF2015-10-12
00840861100064Hemoflow™Fresenius Medical Care Holdings, Inc.MSF2015-09-24
10840861100054Hemoflow™Fresenius Medical Care Holdings, Inc.MSF2015-09-24
10840861100061Hemoflow™Fresenius Medical Care Holdings, Inc.MSF2015-09-24