Cure Catheter® Closed System
GUDID 10815947020694
Closed System Complete Urinary Catheterization System, Coudé Tip
CURE MEDICAL LLC
Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use Single-administration urethral catheterization kit, single-use| Primary Device ID | 10815947020694 |
| NIH Device Record Key | 91070664-fe3c-46bd-a68d-b3998435744f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cure Catheter® Closed System |
| Version Model Number | CS14C |
| 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 |
| 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 | 00815947020697 [Primary] |
| GS1 | 10815947020694 [Package] Contains: 00815947020697 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 |
Trademark Results [Cure Catheter]
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 |
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