FDA.reportPublic FDA data

Molded Products, Inc.

Primary DI
B144MPC8251
Brand
Molded Products, Inc.
Company
MOLDED PRODUCTS, INC.
Model
MPC-825
Catalog number
MPC-825
Device description
Male to Male Recirculation Connector
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
FIDTubing, Dialysate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIDTubing, DialysateGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010712000DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINESMolded Products, Inc.2001-09-27FID

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B144MPC8253PackageHIBCC6In Commercial Distribution
B144MPC8251PrimaryHIBCC0
B144MPC8250Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system dialysate delivery setA collection of non-powered, non-sterile devices intended to be integrated within a haemodialysis system to allow for mixing and delivery of dialysate solution from a powered delivery unit (not included) to the dialyser (not included). The set includes mixing chambers to allow the dialysate to be mixed from a concentrate solution, pumping reservoirs designed to be compressed by an actuator(s) within the delivery unit to displace the dialysate, and an array of tubing/connectors; it is intended to be used in the home and healthcare settings. This is a single-use device.

Regulatory Flags#

DUNS number
157506015
Device count
25
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
B144MPC793A1Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-10-07
B144MPC767WS1Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC1015B2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC1015R2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC1015W2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC1016B2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC1016R2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC1016W2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC767WS4Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC769PP1Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC793N1Molded Products, Inc.MOLDED PRODUCTS, INC.FID2024-08-05
B144MPC1014B2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC1014R2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC1014W2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC1451Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC774WEDPM2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC7751Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC77XW2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC785PVDF1Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC791B2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC791R2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC791W2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC7931Molded Products, Inc.MOLDED PRODUCTS, INC.FID2022-10-04
B144MPC1005B2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2019-09-04
B144MPC1005R2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2019-09-04
B144MPC1005W2Molded Products, Inc.MOLDED PRODUCTS, INC.FID2019-09-04
B144MPC6201Molded Products, Inc.MOLDED PRODUCTS, INC.FID2019-09-04
B144MPC6401Molded Products, Inc.MOLDED PRODUCTS, INC.FID2019-09-04
B144MPC650F1Molded Products, Inc.MOLDED PRODUCTS, INC.FID2019-09-04
B144MPC6651Molded Products, Inc.MOLDED PRODUCTS, INC.FID2019-09-04