FDA.reportPublic FDA data

Molded Products, Inc.

Primary DI
B144MPC1153
Brand
Molded Products, Inc.
Company
MOLDED PRODUCTS, INC.
Model
MPC-115
Catalog number
MPC-115
Device description
Female Luer Lock - White - Replacement Cap
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
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925927000MPC-1000 INJECTION CAP/PLUGMolded Products, Inc.1993-08-16FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B144MPC1151PackageHIBCC100In Commercial Distribution
B144MPC1152PackageHIBCC3In Commercial Distribution
B144MPC1153PackageHIBCC25In Commercial Distribution
B144MPC1150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter disinfection capA sterile (or with sterile fluid path) cap intended to be placed on one of the alternative connectors in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
157506015
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
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

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