Cure Catheter® Closed System

GUDID 10815947020670

Closed System Complete Urinary Catheterization System, Straight Tip

CURE MEDICAL LLC

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 10815947020670
• NIH Device Record Key: 539a2d44-34fb-435e-8652-d09d70939415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cure Catheter® Closed System
• Version Model Number: CS14
• Company DUNS: 070643426
• Company Name: CURE MEDICAL LLC
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18004228811
• Email: cic@convatec.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815947020673 [Primary]
GS1	10815947020670 [Package]; Contains: 00815947020673; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080881

FDA Product Code

• FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Cure Catheter® Closed System]

• 00815947020932: Closed System Single Urinary Catheterization System with Catheter Control Feature, Coudé Tip
• 10815947020922: Closed System Single Urinary Catheterization System with Catheter Control Feature, Straight Tip
• 10815947020915: Closed System Single Urinary Catheterization System with Catheter Control Feature, Straight Tip
• 10815947020908: Closed System Single Urinary Catheterization System with Catheter Control Feature, Straight Tip
• 10815947020892: Closed System Single Urinary Catheterization System with Catheter Control Feature, Straight Tip
• 00815947020888: Closed System Single Urinary Catheterization System with Catheter Control Feature, Straight Tip
• 00815947020871: Closed System Complete Urinary Catheterization System with Catheter Control Feature, Coudé Tip
• 10815947020861: Closed System Complete Urinary Catheterization System with Catheter Control Feature, Straight Ti
• 00815947020857: Closed System Complete Urinary Catheterization System with Catheter Control Feature, Straight Ti
• 10815947020847: Closed System Complete Urinary Catheterization System with Catheter Control Feature, Straight Ti
• 10815947020830: Closed System Complete Urinary Catheterization System with Catheter Control Feature, Straight Ti
• 00815947020826: Closed System Complete Urinary Catheterization System with Catheter Control Feature, Straight Ti
• 10815947020694: Closed System Complete Urinary Catheterization System, Coudé Tip
• 10815947020687: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020670: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020663: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020656: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020649: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020632: Closed System Single Urinary Catheterization System, Coudé Tip
• 10815947020625: Closed System Single Urinary Catheterization System, Straight Tip
• 10815947020618: Closed System Single Urinary Catheterization System, Straight Tip
• 00815947020604: Closed System Single Urinary Catheterization System, Straight Tip
• 10815947020595: Closed System Single Urinary Catheterization System, Straight Tip
• 10815947020588: Closed System Single Urinary Catheterization System, Straight Tip
• 10815947020571: Closed System Complete Urinary Catheterization System, Coudé Tip
• 10815947020564: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020557: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020540: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020533: Closed System Complete Urinary Catheterization System, Straight Tip
• 10815947020526: Closed System Complete Urinary Catheterization System, Straight Tip