Femoral Catheter

Basic Information

• Brand Name: Femoral Catheter
• Primary DI: 00884908053968
• Version / Model: TRAY #141
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-27
• Public Version: 5
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: a081d464-488f-4bc6-98ea-1f366be4da46
• Distribution End Date: 2017-05-24

Device Description

9F X 14CM STRAIGHT FEMORAL CATHETER KIT

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
LFK	CATHETER, FEMORAL	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15023	Femoral artery/vein access catheter	A thin, flexible tube intended to be surgically inserted into the femoral artery or the femoral vein to provide an alternative access to a patient's vasculature, typically when other access routes are not viable or are exhausted. It may be used for continuous arteriovenous (AV) haemofiltration, the delivery of chemotherapeutic agents, or for other chronic applications to avoid repetitive injections. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884908053963	GS1	box	10	Not in Commercial Distribution	2017-05-24
Primary	00884908053968	GS1

Customer Contacts

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