Ritus

GUDID 10884521852730

Pediatric Peritoneal Dialysis, Catheter Curl Cath, 1 Preperitoneal Cuff

Mozarc Medical US LLC

Peritoneal dialysis catheter, acute/chronic

• Primary Device ID: 10884521852730
• NIH Device Record Key: 421b79c3-eaba-45c2-9ce4-e9e127430ffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ritus
• Version Model Number: 8815677001
• 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
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com
• Phone: +39053529111
• Email: RegulatoryOperations@mozarcmedical.com

Device Dimensions

• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 Centimeter
• Length: 39 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
• 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
• 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
• 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	10884521852730 [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: 2025-12-05
• Device Publish Date: 2025-11-27

On-Brand Devices [Ritus]

• 10884521797185: Peritoneal Dialysis Catheter Tunneling Device and Plug
• 10884521853089: Neonatal Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs
• 10884521853072: Neonatal Peritoneal Dialysis Catheter,Tenckhoff, 1 Cuff
• 10884521853065: Pediatric Peritoneal Dialysis Catheter,Curl Cath, 1 Cuff
• 10884521853041: Neonatal Peritoneal Dialysis Catheter,Tenckhoff, 1 Cuff
• 10884521853034: Peritoneal Dialysis Catheter,Oreopoulos-Zellerman Curl Cath, 1 Cuff, 1 Bubble,63 cm
• 10884521853027: Peritoneal Dialysis Catheter,Oreopoulos-Zellerman Curl Cath, 2 Cuff, 1 Bubble,62 cm
• 10884521853010: Pediatric Peritoneal Dialysis Catheter, Curl Cath, 2 Loose Cuffs
• 10884521852983: Peritoneal Dialysis Catheter,Curl Cath, 2 Cuffs
• 10884521852969: Peritoneal Dialysis Catheter,Swan Neck Oreopoulos-Zellerman, 2 Cuff Left,44.5 cm
• 10884521852952: Peritoneal Dialysis Catheter,Swan Neck Missouri, 2 Cuff Left,44.5 cm
• 10884521852945: Peritoneal Dialysis Catheter,Swan Neck Missouri Curl Cath, 2 Cuff Left,62.5 cm
• 10884521852938: Peritoneal Dialysis Catheter,Swan Neck Missouri Curl Cath, 2 Cuff Right,62.5 cm
• 10884521852907: Presternal Peritoneal Dialysis Catheter,Swan Neck Missouri,112.8 cm
• 20884521852898: Peritoneal Dialysis Catheter,Moncrief-Popovich Swan Neck Curl Cath, 2 Cuff,62.5 cm
• 10884521852884: Neonatal Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs
• 10884521852877: Neonatal Peritoneal Dialysis Catheter,Tenckhoff, 1 Cuff
• 10884521852860: Pediatric Peritoneal Dialysis Catheter, Swan Neck Curl Cath, 2 Cuffs
• 10884521852853: Peritoneal Dialysis Catheter Swan Neck Curl Cath, 2 Cuffs
• 10884521852846: Peritoneal Dialysis Catheter Swan Neck Curl Cath, 2 Cuffs
• 10884521852808: Peritoneal Dialysis Catheter,Tenckhoff, Missouri Oreopoulos-Zellerman 2 Cuffs, 2 Disks, 1 Bead,4
• 10884521852792: Pediatric Peritoneal Dialysis Catheter, Swan Neck Tenckhoff, 2 Cuffs Left
• 10884521852761: Pediatric Peritoneal Dialysis Catheter,Curl Cath, 1 Cuff,44.25 cm
• 10884521852754: Peritoneal Dialysis Catheter Kit, Curl Cath, 1 Preperitoneal Cuff
• 10884521852747: Peritoneal Dialysis Catheter Kit,Universal Tenckhoff, 1 Preperitoneal Cuff
• 10884521852730: Pediatric Peritoneal Dialysis, Catheter Curl Cath, 1 Preperitoneal Cuff
• 10884521852709: Neonatal Peritoneal Dialysis Catheter Tenckhoff, 2 Cuff
• 10884521852693: Neonatal Peritoneal Dialysis Catheter, Tenckhoff, 1 Subcutaneous Cuff
• 10884521852686: Pediatric Peritoneal Dialysis Catheter, Tenckhoff, 1 Subcutaneous Cuff
• 10884521852648: Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs
• 10884521852631: Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs
• 20884521811192: Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.035"" x 27.7"" (0.889 mm x 70
• 10884521811188: Dialysis Catheter Accessory,Dilator,10 Fr/Ch (3.3 mm), 15 cm
• 20884521811123: Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.038"" x 27.7"" (0.965 mm x 70
• 20884521811116: Dialysis Catheter Accessory,Introducer Needle,18 G (1.27 mm) x 7 cm
• 10884521811102: Peritoneal Dialysis Accessory,Medical Grade Silicone Adhesive, Type A