FDA.reportPublic FDA data

Molded Products, Inc.

Primary DI
B144MPC60DR1
Brand
Molded Products, Inc.
Company
MOLDED PRODUCTS, INC.
Model
MPC-60D-R
Catalog number
MPC-60D-R
Device description
Dialysate Port Storage Cap - Red
Published
2019-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K010366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010366000DISPOSABLE STORAGE CAPMolded Products, Inc.2001-11-28FJI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B144MPC60DR3PackageHIBCC20In Commercial Distribution
B144MPC60DR1PrimaryHIBCC0
B144MPC60DR0Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
157506015
Device count
200
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B144MPC1500Molded Products, Inc.MPC-150MPC-1502016-11-03
B144MPC1550Molded Products, Inc.MPC-155MPC-1552018-01-05
B144MPC1600Molded Products, Inc.MPC-160MPC-1602018-01-05
B144MPC1000Molded Products, Inc.MPC-100MPC-1002016-09-08
B144MPC1100Molded Products, Inc.MPC-110MPC-1102018-01-04
B144MPC1810Molded Products, Inc.MPC-181MPC-1812019-09-04
B144MPC1813Molded Products, Inc.MPC-181MPC-1812019-09-04
B144MPC852Molded Products, Inc.MPC-85MPC-852018-01-04
B144MPC85TE2Molded Products, Inc.MPC-85TEMPC-85TE2016-12-16
B144MPC793A1Molded Products, Inc.MPC-793-AMPC-793-A2024-10-07
B144MPC767WS1Molded Products, Inc.MPC-767-W-SMPC-767-W-S2024-08-05
B144MPC1015B2Molded Products, Inc.MPC-1015-BMPC-1015-B2024-08-05
B144MPC1015R2Molded Products, Inc.MPC-1015-RMPC-1015-R2024-08-05
B144MPC1015W2Molded Products, Inc.MPC-1015-WMPC-1015-W2024-08-05
B144MPC1016B2Molded Products, Inc.MPC-1016-BMPC-1016-B2024-08-05
B144MPC1016R2Molded Products, Inc.MPC-1016-RMPC-1016-R2024-08-05
B144MPC1016W2Molded Products, Inc.MPC-1016-WMPC-1016-W2024-08-05
B144MPC767WS4Molded Products, Inc.MPC-767-W-SMPC-767-W-S2024-08-05
B144MPC769PP1Molded Products, Inc.MPC-769-PPMPC-769-PP2024-08-05
B144MPC793N1Molded Products, Inc.MPC-793-NMPC-793-N2024-08-05

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
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
10858293006271Auto-Vent Port CapsREPROCESSING PRODUCTS CORPORATIONFJI2019-08-26