FDA.reportPublic FDA data

Polyflux

Primary DI
37332414041473
Brand
Polyflux
Company
Gambro Dialysatoren GmbH
Model
8LR
Catalog number
104333
Device description
The POLyflux LR is intended for use in hemodialysis for the treatment of chronic or acute renal failure,The POLyflux LR may be reprocessed for reuse o
Published
2015-10-12
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
K043342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043342000POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal Products2005-05-27FJI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414041473PackageGS116In Commercial Distribution
07332414041472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241404147337332414041473
07332414041472073324140414727332414041472

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
316150549
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414102500Ultrafilter U 90001120621120622021-03-31
07332414126957U9000 Plus ultrafilter9558259558252021-12-30
07332414031770POLYFLUX17R1017852015-10-12
07332414031787POLYFLUX21R1006912015-10-12
07332414036140POLYFLUX24R1043242015-10-12
07332414036416Polyflux17L1020582015-10-08
07332414036423Polyflux14L1020572015-10-12
07332414037925Polyflux140H1035302015-10-12
07332414037932Polyflux170H1035792015-10-12
07332414041465POLYFLUX6LR1043292015-10-12
07332414041472POLYFLUX8LR1043332015-10-12
07332414047108POLYFLUX10LR1043112015-10-12
07332414048181Polyflux21L1041762015-10-12
07332414048198Polyflux210H1035802015-10-12
07332414114916Revaclear3001147452015-10-12
07332414114923Revaclear4001147462015-10-12
07332414126193REVACLEARRevaclear 300114745M2021-11-08
07332414126209REVACLEARRevaclear 400114746M2021-11-08
07332414015473Adsorba Hemoperfusion cartridge300C1012232016-09-24
07332414015480Adsorba Hemoperfusion cartridge150C1010972016-09-24

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
37332414047109PolyfluxGambro Dialysatoren GmbHMSF2015-10-12
00840861100057Hemoflow™Fresenius Medical Care Holdings, Inc.MSF2015-09-24
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