Argyle

Basic Information

• Brand Name: Argyle
• Primary DI: 10884521055476
• Version / Model: 8888411447
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-15
• Public Version: 5
• Public Version Date: 2023-08-01
• Public Version Status: Update
• Public Device Record Key: fe9e1176-18bb-45c6-a016-e48989b36b4a

Device Description

Peritoneal Dialysis Catheter, Tenckhoff, 2 Cuffs

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: MR Safe
• 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
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47086	Peritoneal dialysis catheter, chronic	A tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane. It is usually surgically or endoscopically implanted, percutaneously, for long-term use; it may be provided with Dacron cuffs to promote tissue ingrowth for the prevention of fluid leaks and bacterial penetration. It may be used in manual continuous ambulatory peritoneal dialysis (CAPD), automated continuous cyclic peritoneal dialysis, intraperitoneal chemotherapy, or to eliminate fluid overload in congestive heart failure. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521055476	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180485	000
K862046	000

Device Sizes

Type	Value	Unit	Text
Length	47	Centimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 20 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: – 270 Degrees Fahrenheit