FDA.reportPublic FDA data

Hemoflow™

Primary DI
10840861100054
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970700000FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXFresenius USA, Inc.1998-09-15MSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840861100054PackageGS112In 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

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
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
00840861100057Hemoflow™Fresenius Medical Care Holdings, Inc.MSF2015-09-24
00840861100064Hemoflow™Fresenius Medical Care Holdings, Inc.MSF2015-09-24
10840861100061Hemoflow™Fresenius Medical Care Holdings, Inc.MSF2015-09-24