Argyle

GUDID 20884521055848

Peritoneal Dialysis Catheter,Curl Cath, 2 Cuff

Covidien LP

Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic Peritoneal dialysis catheter, chronic

• Primary Device ID: 20884521055848
• NIH Device Record Key: 37f0a9f7-ea6e-49e7-bebe-3eb3f277aa68
• Commercial Distribution Discontinuation: 2018-03-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Argyle
• Version Model Number: 8888422295
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521055841 [Primary]
GS1	20884521055848 [Package]; Contains: 10884521055841; Package: PACK_OR_INNER_PACK [5 Units]; Discontinued: 2018-03-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890288

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-10-14
• Device Publish Date: 2015-09-28

On-Brand Devices [Argyle]

• 20884521003948: Chronic Catheter Accessory,Injection Sealing Cap
• 20884521003917: Peritoneal Dialysis Accessory,Beta-Cap Clamp
• 10884521009981: Acute Catheter Accessory,Y-Adapter
• 10884521056015: Peritoneal Dialysis Catheter,Oreopoulos-Zellerman Curl Cath, 1 Cuff, 1 Bubble,63 cm
• 10884521004610: Peritoneal Dialysis Catheter,Swan Neck Curl Cath, 2 Cuff Left,62.5 cm
• 20884521024332: Chronic Catheter Accessory,Oval Pull Apart Introducer Set
• 20884521024318: Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,16
• 20884521024301: Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,10
• 20884521024295: Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,12
• 20884521024288: Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,14
• 10884521070356: Personal Protective Equipment, Maximal Sterile Barrier Precautions Pack
• 10884521004290: Peri-Patch Peritoneal Dialysis Catheter,Repair Kit
• 10884521054875: Peritoneal Dialysis Catheter,Curl Cath, 2 Loose Cuffs
• 10884521004092: Peritoneal Dialysis Catheter,Curl Cath, 1 Preperitoneal Cuff
• 10884521004085: Peritoneal Dialysis Catheter,Curl Cath, 2 Cuffs
• 10884521004078: Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs
• 10884521004061: Peritoneal Dialysis Catheter,Tenckhoff, 1 Subcutaneous Cuff
• 10884521004054: Peritoneal Dialysis Catheter,Universal Tenckhoff, 2 Cuffs
• 10884521004047: Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs
• 10884521003927: Peritoneal Dialysis Accessory,Medical Grade Silicone Adhesive, Type A
• 10884521084520: Peritoneal Dialysis Accessory,Titanium Catheter Extender with Tubing
• 00884521061357: Left Ventricular Sump Vent Catheter
• 10884521003958: Dialysis Catheter Accessory,Introducer Needle,18 G (1.27 mm) x 7 cm
• 20884521070339: Acute Single Lumen Catheter Kit,Straight Extension,8 Fr/Ch (2.7 mm) x 15 cm
• 20884521070322: Acute Single Lumen Catheter,Straight Extension,8 Fr/Ch (2.7 mm) x 19.5 cm
• 20884521006673: Acute Single Lumen Catheter Kit,Straight Extension,8 Fr/Ch (2.7 mm) x 19.5 cm
• 10884521004757: Peritoneal Dialysis Accessory,Titanium Catheter Extender,Adult
• 10884521004740: Peritoneal Dialysis Accessory,Two Part Titanium Luer Adapter
• 10884521004153: Peritoneal Dialysis Catheter, Tenckhoff, 1 Preperitoneal Cuff
• 10884521004771: Peritoneal Dialysis Accessory Catheter Straightening Stylet
• 10884521004764: Peritoneal Dialysis Accessory Catheter Straightening Stylet
• 10884521004115: Peritoneal Dialysis Catheter,Curl Cath, 2 Cuffs
• 20884521004037: Peritoneal Dialysis Accessory,Blunt Tunneling Stylet
• 10884521811256: Peritoneal Dialysis Accessory Catheter Straightening Stylet
• 20884521055817: Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuff, Straight,Bent 130
• 20884521055848: Peritoneal Dialysis Catheter,Curl Cath, 2 Cuff
• 10884521084506: Peritoneal Dialysis Accessory,Titanium Adapter
• 10884521086821: Peritoneal Dialysis Catheter,Universal Tenckhoff, 1 Subcutaneous Cuff,46 cm
• 10884521056732: Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuff,32 cm
• 10884521053366: Peritoneal Dialysis Catheter,Tenckhoff, 2 Loose Cuffs,42 cm
• 10884521004146: Neonatal Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuff,31 cm
• 10884521004139: Neonatal Peritoneal Dialysis Catheter,Tenckhoff, 1 Subcutaneous Cuff,31 cm
• 10884521004122: Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 1 Subcutaneous Cuff,37 cm
• 10884521004108: Peritoneal Dialysis Catheter,Curl Cath, 1 Preperitoneal Cuff,57 cm
• 20884521003962: Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.038"" x 27.7"" (0.965 mm x 70
• 10884521004207: Pediatric Peritoneal Dialysis, Catheter Curl Cath, 1 Preperitoneal Cuff
• 10884521004191: Peritoneal Dialysis Catheter,Universal Tenckhoff, 1 Preperitoneal Cuff,46 cm
• 20884521004006: Dialysis Catheter Accessory,Dilator,10 Fr/Ch (3.3 mm), 15 cm
• 20884521003993: Dialysis Catheter Accessory,Dilator,8 Fr/Ch (2.7 mm), 15 cm
• 20884521003979: Peritoneal Dialysis Accessory,Beta-Cap Adapter