FDA.reportPublic FDA data

Polyflux

Primary DI
37332414036424
Brand
Polyflux
Company
Gambro Dialysatoren GmbH
Model
14L
Catalog number
102057
Device description
The Polyflux L is intended for use in haemodialysis for the treatment of chronic or acute renal failure
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJIDIALYZER, CAPILLARY, HOLLOW FIBER
MSFHEMODIALYZER, RE-USE, HIGH FLUX

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJIDialyzer, Capillary, Hollow FiberGastroenterology, Urology2
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
37332414036424PackageGS124In Commercial Distribution
07332414036423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241403642437332414036424
07332414036423073324140364237332414036423

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 Area1.4Square meter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
false

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

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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
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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