PRO-LINE CT PRESSURE INJECTABLE CVC (ISOPLAST) (SINGLE/DOUBLE 5F-6FX60CM)PRO-LIN

Basic Information

• Brand Name: PRO-LINE CT PRESSURE INJECTABLE CVC (ISOPLAST) (SINGLE/DOUBLE 5F-6FX60CM)PRO-LIN
• Primary DI: 00884908137361
• Version / Model: MD28036221
• Catalog Number: MD28036221
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-06
• Public Version: 3
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 49f8e73b-4514-4273-80d5-153dc8814f35

Device Description

6F X 60CM DUAL LUMEN6F X 60CM DU PRO-LINE®CT W/CUFF @ 2CM BASIC IR SETBASIC IR 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: 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
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10729	Centrally-inserted central venous catheter	A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884908137366	GS1	box	5	In Commercial Distribution
Primary	00884908137361	GS1

Customer Contacts

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