Arterial Line Kit

Basic Information

• Brand Name: Arterial Line Kit
• Primary DI: 00886333221097
• Version / Model: 498511
• Catalog Number: 498511
• Company Name: ARGON MEDICAL DEVICES, INC.
• Labeler DUNS: 140727624
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: e597f545-fb53-456e-a066-8e9060a111ea
• Distribution End Date: 2024-01-31

Device Description

Arterial Line Kit 20ga x 3"

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: 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: Yes
• 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
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	878.4450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886333221091	GS1	Box	10	Not in Commercial Distribution	2024-01-31
Primary	00886333221097	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K780871	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20ga x 3"