Molded Products, Inc.

Basic Information

• Brand Name: Molded Products, Inc.
• Primary DI: B144UM872360
• Version / Model: UM-872-36
• Catalog Number: UM-872-36
• Company Name: MOLDED PRODUCTS, INC.
• Labeler DUNS: 157506015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 4
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: ff84ce00-352c-4189-a6fd-4a445625d277

Device Description

STERILE ACCESS & RETURN LINE SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
34999	Haemodialysis blood tubing set, single-use	A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B144UM872360	HIBCC
Package	B144UM872361	HIBCC	Bag	25	In Commercial Distribution
Package	B144UM872364	HIBCC	Case	8	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K003712	000