Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 00884521149543
• Version / Model: 8888591008
• Catalog Number: 8888591008
• 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: 5
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: e82da807-851b-470a-bf8d-71d061deffbf

Device Description

Aortic Perfusion Cannula,Angled Tip

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: Yes
• 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
37696	Cerebral perfusion catheter	A sterile, flexible tube designed for retrograde cerebral perfusion with oxygenated cold blood. It is a two-lumen tube with several side holes and a balloon attached at its tip. The device is inserted into the internal jugular vein via a puncture in such a way that the holes remain in the vein so they can be used for cerebral perfusion even in the case of competent venous valves at the jugular-subclavian junction. It is then advanced until the inflation of the balloon at its tip occludes the drainage veins (superior vena cava and azygos vein). It is used for brain protection during profound hypothermic circulatory arrest during aortic surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00884521063214	GS1	CASE	10	In Commercial Distribution
Primary	00884521149543	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	10	French

Storage Conditions

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