PRO-FUSE®

Basic Information

• Brand Name: PRO-FUSE®
• Primary DI: 00884908148886
• Version / Model: MIPP80ALS
• Catalog Number: MIPP80ALS
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-31
• Public Version: 2
• Public Version Date: 2022-06-22
• Public Version Status: Update
• Public Device Record Key: d31ac122-9d3d-4db7-846f-10bb7e0fcd9c
• Distribution End Date: 2022-06-14

Device Description

8F PLASTIC Pro-Fuse® LOW PROFILE CT PORT W/LOW PROFIL SILICONE FILLED SUTURESILICONE F HOLES W/ATTACHABLEHOLES W/ATTACH ChronoFlex®POLYURETHANE CATHETER W/5F Micro-Stick® INTRODUCER SETINTRODUCER SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• 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
LJT	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR	General Hospital	880.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61494	Vascular port/catheter	A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884908148881	GS1	box	5	Not in Commercial Distribution	2022-06-14
Primary	00884908148886	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]