Argyle

GUDID 10884521852822

Peritoneal Dialysis Catheter, Tenckhoff, 2 Cuffs

Mozarc Medical US LLC

Peritoneal dialysis catheter, acute/chronic

• Primary Device ID: 10884521852822
• NIH Device Record Key: 68302b90-043a-4cfd-b4f4-63d2972f6cd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Argyle
• Version Model Number: 8888411447
• Company DUNS: 118997146
• Company Name: Mozarc Medical US LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com

Device Dimensions

• Length: 47 Centimeter
• Length: 47 Centimeter
• Length: 47 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 270 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 270 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 270 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521852822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180485

FDA Product Code

• FJS: Catheter, Peritoneal, Long-Term Indwelling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-16
• Device Publish Date: 2026-02-06

Devices Manufactured by Mozarc Medical US LLC

• 10884521852822 - Argyle: 2026-02-16Peritoneal Dialysis Catheter, Tenckhoff, 2 Cuffs
• 10884521852822 - Argyle: 2026-02-16 Peritoneal Dialysis Catheter, Tenckhoff, 2 Cuffs
• 10884521811102 - Ritus: 2025-12-05 Peritoneal Dialysis Accessory,Medical Grade Silicone Adhesive, Type A
• 20884521811116 - Ritus: 2025-12-05 Dialysis Catheter Accessory,Introducer Needle,18 G (1.27 mm) x 7 cm
• 20884521811123 - Ritus: 2025-12-05 Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.038"" x 27.7"" (0.965 mm x 70 cm)
• 10884521811188 - Ritus: 2025-12-05 Dialysis Catheter Accessory,Dilator,10 Fr/Ch (3.3 mm), 15 cm
• 20884521811192 - Ritus: 2025-12-05 Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.035"" x 27.7"" (0.889 mm x 70 cm)
• 10884521852631 - Ritus: 2025-12-05 Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs
• 10884521852648 - Ritus: 2025-12-05 Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs