Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10884521025523
• Version / Model: 8888573550
• Catalog Number: 8888573550
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-27
• Public Version: 2
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: ef84719d-6bcd-4924-baa1-adb4a80043d9

Device Description

Silicone Mediastinal Drain

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBS	CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10741	Pericardiocentesis catheter	A flexible tube designed for the drainage of effusion from the pericardial sac (the pericardium). It typically consists of a thin walled, flexible, plastic [e.g., polyethylene (PE)] tube with a J-shaped distal tip perforated with multiple holes in both its convex and concave sides. It is introduced percutaneously into the pericardium, anchored in place, and connected to a water-seal drainage system. It can be left in situ for some days or weeks during the treatment of cardiac tamponade and can be used for the irrigation/instillation of drugs (e.g., antibiotics, cytotoxic agents) into the pericardium. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521025520	GS1	CASE	10	In Commercial Distribution
Primary	10884521025523	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	28	French

Storage Conditions

• Type: Special Storage Condition, Specify