Argyle 8815544001

GUDID 20884521024288

Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,14 Fr/Ch (4.7 mm)

Covidien LP

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20884521024288
• NIH Device Record Key: 500e7a5d-9062-4e07-ba7c-2c292646e23a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Argyle
• Version Model Number: 8815544001
• Catalog Number: 8815544001
• 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: 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: +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
• 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 Dimensions

• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521024281 [Primary]
GS1	20884521024288 [Package]; Contains: 10884521024281; Package: PACK_OR_INNER_PACK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871730

FDA Product Code

• FKO: CATHETER, PERITONEAL DIALYSIS, SINGLE USE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-24

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