RediCath HS1010
GUDID 50851809002178
RediCath Hydrophilic Catheter
HR PHARMACEUTICALS INC.
Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter Urine-sampling urethral catheter| Primary Device ID | 50851809002178 |
| NIH Device Record Key | 303c4c39-e59d-482c-9d36-0b7ff1fa580f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RediCath |
| Version Model Number | HS1010 |
| Catalog Number | HS1010 |
| Company DUNS | 828918164 |
| Company Name | HR PHARMACEUTICALS INC. |
| 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 |
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 | |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851809002173 [Primary] |
| GS1 | 10851809002170 [Package] Contains: 00851809002173 Package: Box [30 Units] In Commercial Distribution |
| GS1 | 50851809002178 [Package] Contains: 10851809002170 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142767
FDA Product Code
| GBM | CATHETER, URETHRAL |
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 | 2020-02-28 |
| Device Publish Date | 2020-02-20 |
On-Brand Devices [RediCath]
| 00851809002982 | RediCath Hydrophilic Coude Catheter |
| 00851809002975 | RediCath Hydrophilic Coude Catheter |
| 00851809002968 | RediCath Hydrophilic Coude Catheter |
| 50851809002994 | RediCath Hydrophilic Coude Catheter |
| 50851809002956 | RediCath Hydrophilic Catheter |
| 50851809002949 | RediCath Hydrophilic Catheter |
| 10851809002934 | RediCath Hydrophilic Catheter |
| 50851809002925 | RediCath Hydrophilic Catheter |
| 50851809002918 | RediCath Hydrophilic Catheter |
| 50851809002345 | RediCath Hydrophilic Catheter |
| 10851809002194 | RediCath Hydrophilic Catheter |
| 50851809002178 | RediCath Hydrophilic Catheter |
| 50851809002154 | RediCath Hydrophilic Catheter |
| 10851809002613 | RediCath Hydrophilic Catheter |
Trademark Results [RediCath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REDICATH 77740205 3794721 Dead/Cancelled |
Ashlar Medical, L.L.C. 2009-05-19 |
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