Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10884521006676
• Version / Model: 8831173011
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 7
• Public Version Date: 2023-05-19
• Public Version Status: Update
• Public Device Record Key: 12d97ae9-4be8-428b-9219-cc6ecb77c853

Device Description

Acute Single Lumen Catheter Kit,Straight Extension,8 Fr/Ch (2.7 mm) x 19.5 cm

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
LFJ	CATHETER, SUBCLAVIAN	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62647	Single-lumen haemodialysis catheter, peripheral vascular	A sterile, flexible, single-lumen tube intended to be used for short-term (< 30 days) peripheral arteriovenous access during extracorporeal blood therapies (i.e., haemodialysis haemoperfusion and/or apheresis), to conduct blood from a patient and to return it after extracorporeal circulation. It is designed to withstand elevated pressures associated with arteriovenous access (i.e., via shunt or fistula), and may be intended for single-needle technique (i.e., sequential bidirectional flow) and/or double-needle technique (i.e., using two catheters). Devices dedicated to catheter introduction/function (e.g., introducer needle, stylet) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521006673	GS1	PACK_OR_INNER_PACK	5	In Commercial Distribution
Primary	10884521006676	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	19.5	Centimeter
Catheter Gauge	8	French