CliniClean
CHLORHEXIDINE GLUCONATE 4%
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008502431 | 3008502431 | HR PHARMACEUTICALS, INC d/b/a HR HealthCare | 1 | Y | 2026-01-01 | 3630 Concord Rd York PA US 17402 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850025153027 | Vitus - "Vitus 2"" Seal Thin" | +1(717)252-1110 | sbenser@hrpharma.com |
| 00850025153034 | Vitus - "Vitus 2"" Seal Standard" | +1(717)252-1110 | sbenser@hrpharma.com |
| 00850025153041 | Vitus - "Vitus 4"" Seal" | +1(717)252-1110 | sbenser@hrpharma.com |
| 00850025153089 | Vitus - Vitus 1/3 Crescent Barrier Ext | +1(717)252-1110 | sbenser@hrpharma.com |
| 00850058254333 | TruLock - TruLock™ Foley Securement Device, For 2-Way Foley, Large Swivel Clamp on Mesh Cloth Base, and Skin Prep Pad | +1(717)252-1110 | sbenser@hrhealthcare.com |
| 00850058254364 | TruLock - TruLock™ Foley Securement Device, For 3-Way Foley,3-Way Swivel Clamp on Mesh Cloth Base, and Skin Prep Pad | +1(717)252-1110 | sbenser@hrhealthcare.com |
| 00850058254371 | TruLock - TruLock™ Pediatric Foley Securement Device, For 2-Way Foley, Large Swivel Clamp on Pediatric Foam Base, and Skin Prep Pad | +1(717)252-1110 | sbenser@hrhealthcare.com |
| 00850067913009 | TruLock - "TruLock Foley Strap, 30""" | 717-252-1110 | sbenser@hrhealthcare.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 117513 | 1662746862 | K970893 | ULTRASOUND TRANSDUCER DRAPE | FYA | 1997-10-20 |
| 117513 | 1290855401 | K941488 | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER | EZL | 1994-11-30 |
| 117513 | 1583429819 | K260502 | Liv Pre-lubricated Intermittent Catheter | EZD | 2026-03-12 |
| 117513 | 1690427504 | K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | EZD | 2026-01-29 |
| 117513 | 1452408663 | K222677 | Intermittent nelaton catheter for single use | EZD | 2023-04-05 |
| 117513 | 1264043882 | K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | EZL | 2021-04-08 |
| 117513 | 1054918431 | K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mL | EZL | 2020-03-31 |
| 117513 | 1997905139 | K200134 | Jimushi Sterile Urethral Catheter for single use | GBM | 2020-06-01 |
| 117513 | 1961190971 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | MUI | 2018-06-13 |
| 117513 | 1521190958 | K173340 | Yikang Latex Foley Catheter | EZL | 2018-07-13 |
| 117513 | 1897115203 | K172851 | Microcyn Plus Antimicrobial Wound Care Solution | FRO | 2017-11-15 |
| 117513 | 1470558191 | K130908 | DISPOSABLE SILICONE FOLEY CATHETER | EZL | 2013-10-03 |
| 117513 | 1905193846 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | 2008-10-08 |
| 117513 | 1511138396 | K080878 | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) | KOD | 2008-07-17 |
| 117513 | 1605778619 | K030293 | AMSURE RED RUBBER URETHRAL CATHETER | EYB | 2004-02-04 |
| 117513 | 1116244729 | ||||
| 117513 | 1169225154 | ||||
| 117513 | 1196487039 | ||||
| 117513 | 1421776500 | ||||
| 117513 | 1471878470 | ||||
| 117513 | 1642807010 | ||||
| 117513 | 1741775367 | ||||
| 117513 | 1746687230 | ||||
| 117513 | 1773863896 | ||||
| 117513 | 1782159090 | ||||
| 117513 | 1970243573 | ||||
| 117513 | 2039616876 | ||||
| 117513 | 2052649782 |
CHLORHEXIDINE GLUCONATE 4%
HR Pharmaceuticals, Inc.
HR Pharmaceuticals, Inc.
2021-05-19
2021-05-19
2021-05-19
2023-03-31
2025-03-03
2025-03-03
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2016-09-24
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2018-07-16
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2019-02-12
2026-03-06
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