Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10884521069732
• Version / Model: R8772
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1700
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-10-31
• Public Version Status: Update
• Public Device Record Key: 737f93be-4260-439c-aed7-251259142065

Device Description

DeLee Catheter

Device Characteristics

• Single Use: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOL	CATHETER AND TIP, SUCTION	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34926	Ureteral catheter	A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521069732	GS1
Unit of Use	20884521069739	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	14	French
Length	8.5	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry