Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10884521063204
• Version / Model: 8888590224
• Catalog Number: 8888590224
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2020-10-12
• Public Version Status: Update
• Public Device Record Key: b205860e-5f63-4995-a188-b3a8632a7176

Device Description

Left Ventricular Sump Vent Catheter

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
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17613	Cardiac ventriculography catheter	A flexible tube with specific tip configurations designed to enter the left or right ventricle to perform diagnostic haemodynamic/angiographic procedures with contrast media. The distal tip may have an end hole and/or several side holes. The tube is introduced into a peripheral blood vessel and its distal tip is placed in the left or right ventricle according to the desired ventriculography. Left ventriculography is used to assess impairment of the left ventricle, the presence of ventricular aneurysms or septal defects, or to assess the mitral valve. Right ventriculography is used mostly to asses congenital heart disease. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00884521063207	GS1	CASE	10	In Commercial Distribution
Primary	10884521063204	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	20	Inch
Catheter Gauge	20	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry;AVOID DIRECT SUNLIGHT