TruCath
GUDID 10850045818910
TruCath® 100% Silicone Temperature Sensing Foley Catheter, 10 Fr 5 ml, 2-Way
HR PHARMACEUTICALS INC.
Temperature-monitoring indwelling urethral drainage catheter| Primary Device ID | 10850045818910 |
| NIH Device Record Key | 8f33d465-a071-48f6-bca3-ef92d6b1ceef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruCath |
| Version Model Number | TS1005 |
| Company DUNS | 828918164 |
| Company Name | HR PHARMACEUTICALS INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com | |
| Phone | +1(717)252-1110 |
| sbenser@hrpharma.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Humiditiy = 95% |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850045818913 [Primary] |
| GS1 | 10850045818910 [Package] Contains: 00850045818913 Package: Box [12 Units] In Commercial Distribution |
| GS1 | 50850045818918 [Package] Package: Case [50 Units] In Commercial Distribution |
FDA Product Code
| EZL | CATHETER, RETENTION TYPE, BALLOON |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-09 |
| Device Publish Date | 2024-02-01 |
On-Brand Devices [TruCath]
| 10851809002798 | TruCath intermittent straight pediatric catheter |
| 10851809002781 | TruCath intermittent straight pediatric catheter |
| 50851809002772 | TruCath intermittent straight male catheter |
| 10851809002767 | TruCath intermittent straight male catheter |
| 10851809002750 | TruCath intermittent straight male catheter |
| 10851809002743 | TruCath intermittent straight male catheter |
| 10851809002736 | TruCath intermittent straight male catheter |
| 10851809002729 | TruCath intermittent straight male catheter |
| 50851809002710 | TruCath Intermittent Catheter Insertion Kit |
| 50851809002703 | TruCath Intermittent Catheter Insertion Kit |
| 50851809002604 | TruCath Closed System catheter |
| 50851809002581 | TruCath Closed System catheter |
| 50851809002574 | TruCath Closed System catheter |
| 50851809002567 | TruCath Closed System catheter |
| 50851809002550 | TruCath Closed System Catheter Kit |
| 50851809002543 | TruCath Closed System Catheter Kit |
| 50851809002536 | TruCath Closed System Catheter Kit |
| 50851809002529 | TruCath Closed System Catheter Kit |
| 10851809002323 | TruCath intermittent Coude catheter |
| 50851809002291 | TruCath intermittent Coude catheter |
| 50851809002284 | TruCath intermittent Coude catheter |
| 10851809002279 | TruCath intermittent Coude catheter |
| 50851809002260 | TruCath intermittent Coude catheter |
| 10851809002255 | TruCath intermittent straight female catheter |
| 50851809002246 | TruCath intermittent straight female catheter (no connector) |
| 10851809002231 | TruCath intermittent straight female catheter |
| 50851809002222 | TruCath intermittent straight female catheter |
| 50851809002215 | TruCath intermittent straight female catheter |
| 50851809002208 | TruCath intermittent straight female catheter |
| 50850025153138 | TruCath Night Drainage Bag 2000mL |
| 50850025153121 | TruCath Premium Leg Bag 1000mL |
| 50850025153114 | TruCath Premium Leg Bag 500mL |
| 10850025153390 | Hydrophilic coude catheter 12 fr |
| 10850025153383 | Hydrophilic coude catheter 14 fr |
| 10850025153376 | Male Straight 16FR SOFT |
| 50850025153367 | Male Straight 14FR SOFT |
| 50850025153350 | Male Straight 12FR SOFT |
| 50850025153343 | Pediatric Straight 6FR |
| 10850025153338 | Male Hydro 14FR SOFT |
| 10850025153321 | Male Hydro 12FR SOFT |
| 50850025153312 | Male Hydro Coude 16FR SOFT |
| 10850025153307 | Pediatric Hydro Coude 10FR |
| 10850025153291 | Pediatric Hydro Coude 8FR |
| 10850025153284 | Pediatric Coude 8FR |
| 10850058254231 | TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 24 Fr 5 ml, 2-Way |
| 10850058254224 | TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 22 Fr 5 ml, 2-Way |
| 10850058254217 | TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 20 Fr 5 ml, 2-Way |
| 50850058254208 | TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 18 Fr 5 ml, 2-Way |
| 10850058254194 | TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 16 Fr 5 ml, 2-Way |
| 50850058254185 | TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 14 Fr 5 ml, 2-Way |
Trademark Results [TruCath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUCATH 98454574 not registered Live/Pending |
Wiesman Holdings, LLC 2024-03-18 |
 TRUCATH 90544993 not registered Live/Pending |
Wiesman Holdings, LLC 2021-02-24 |
 TRUCATH 77726172 3894669 Dead/Cancelled |
Smith & Nephew, Inc. 2009-04-30 |
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