| Primary Device ID | 10815947020922 | 
| NIH Device Record Key | 8a2aa5d4-ed07-4372-8dd8-3146039f593f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cure Catheter® Closed System | 
| Version Model Number | CBL16 | 
| 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 | 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 | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Catheter Gauge | 16 French | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00815947020925 [Primary] | 
| GS1 | 10815947020922 [Package] Contains: 00815947020925 Package: Case [100 Units] In Commercial Distribution | 
| KOD | Catheter, Urological | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2017-12-31 | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CURE CATHETER  86125386  4591923 Live/Registered | Cure Medical, LLC 2013-11-21 | 
|  CURE CATHETER  78348044  3110064 Live/Registered | CURE MEDICAL LLC 2004-01-06 |