Molded Products, Inc.

Basic Information

• Brand Name: Molded Products, Inc.
• Primary DI: B144MPC855NS2501
• Version / Model: MPC-855NS.250
• Catalog Number: MPC-855NS.250
• Company Name: MOLDED PRODUCTS, INC.
• Labeler DUNS: 157506015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-09-03
• Public Version: 1
• Public Version Date: 2019-09-11
• Public Version Status: New
• Public Device Record Key: 23560731-3a72-4c57-966f-52ac99ed0c89

Device Description

Non-Sterile DIN Adapter, PVDF, Fits 1/4" ID Tubing

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63863	Haemodialysis dialysate tubing, reusable	A length of tube made of metal and/or synthetic polymer materials intended to deliver haemodialysis dialysate and/or haemodialysis dialysate components (water, haemodialysis concentrate) to and/or from a haemodialysis machine/system. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B144MPC855NS2501	HIBCC
Unit of Use	B144MPC855NS2500	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K003712	000