FDA.reportPublic FDA data

Molded Products, Inc.

Primary DI
B144MPC85TE2
Brand
Molded Products, Inc.
Company
MOLDED PRODUCTS, INC.
Model
MPC-85TE
Catalog number
MPC-85TE
Device description
DIALYSIS TRANSDUCER PROTECTOR - Tamper Evident Packaging
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FIBProtector, Transducer, Dialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIBProtector, Transducer, DialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925978000MPC-80 TRANSDUCERMolded Products, Inc.1994-01-14FIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B144MPC85TE3PackageHIBCC22In Commercial Distribution
B144MPC85TE2PrimaryHIBCC0
B144MPC85TE0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system transducer protectorA device designed to protect a haemodialysis system pressure monitor from contamination and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plastic housing that contains a hydrophobic filter with a reference pore size (e.g., 1 to 2 microns) that helps prevent transfer of by viruses, bacteria, and particulate matter, while preventing the flow of fluids, to the pressure monitor. It may feature tubing and a male Luer lock designed to facilitate replacement of a contaminated transducer protector via a secondary connection on the pressure monitor. This is a single-use device.

Regulatory Flags#

DUNS number
157506015
Device count
125
Lot or batch
true
Expiration date on label
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
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
B144MPC1240Molded Products, Inc.MPC-124MPC-1242024-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948082770036NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FIB2024-07-31
16948082770033NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FIB2024-07-31
B144MPC852Molded Products, Inc.MOLDED PRODUCTS, INC.FIB2018-01-04
B144MPC853Molded Products, Inc.MOLDED PRODUCTS, INC.FIB2018-01-04
B144MPC85TE3Molded Products, Inc.MOLDED PRODUCTS, INC.FIB2016-12-16
04054839076473Millex - FHMERCK MILLIPORE LIMITEDFIB2016-09-01
04054839076565Dualex Plus Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2016-09-01
04054839076572Dualex Ultra Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2016-09-01
04054839076756HydromillexMERCK MILLIPORE LIMITEDFIB2016-09-01
04054839078217Dualex Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2016-09-01
05034480315106PallPall International SàrlFIB2015-10-21
35034480315107PallPall International SàrlFIB2015-10-21
10840861100542FreseniusFresenius Medical Care Holdings, Inc.FIB2015-09-30
20840861100549FreseniusFresenius Medical Care Holdings, Inc.FIB2015-09-30
00383790004503NIPRO TP-SURENIPRO MEDICAL CORPORATIONFIB2015-09-16
10383790004500NIPRO TP-SURENIPRO MEDICAL CORPORATIONFIB2015-09-16
08436037123160Dualex Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2015-09-04
04053252397837Millex - FHMERCK MILLIPORE LIMITEDFIB2015-09-04
04053252660283Dualex Ultra Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2015-09-04
04053252725180HydromillexMERCK MILLIPORE LIMITEDFIB2015-09-04
M535M820062ViraGuard Viral Blocking Patient Transducer ProtectorMEDISYSTEMS CORPORATIONFIB2015-09-01
04053252398018Dualex Plus Transducer ProtectorMERCK MILLIPORE LIMITEDFIB2015-09-01