Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10884521024281
• Version / Model: 8815544001
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-05-18
• Public Version Status: Update
• Public Device Record Key: 500e7a5d-9062-4e07-ba7c-2c292646e23a

Device Description

Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,14 Fr/Ch (4.7 mm)

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
FKO	CATHETER, PERITONEAL DIALYSIS, SINGLE USE	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63230	Vascular catheter introduction set, implantable	A collection of devices which includes an implantable device(s) intended to provide percutaneous, peripheral, arterial access to enable repeated introduction of a catheter (not included) into the vascular system over an extended period (e.g., months) without vascular wound closure. It includes an implantable non-steerable introducer sheath, an inner obturator/occluder, and typically an additional access device(s) [e.g., haemostatic valve, stylet]. The introducer sheath is typically anastomosed to the blood vessel and externalised via a subcutaneous tunnel; the occluder is intended to plug the introducer sheath between uses. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521024288	GS1	PACK_OR_INNER_PACK	5	In Commercial Distribution
Primary	10884521024281	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	14	French