FDA.reportPublic FDA data

Molded Products, Inc.

Primary DI
B144MPC6603
Brand
Molded Products, Inc.
Company
MOLDED PRODUCTS, INC.
Model
MPC-660
Catalog number
MPC-660
Device description
Recirculation Loop / Rinse Line with Sampling Port
Published
2018-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
B144MPC6603PackageHIBCC16In Commercial Distribution
B144MPC6601PrimaryHIBCC0
B144MPC6600Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
157506015
Device count
25
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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