Product code EYZ
- Device name
- System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5250
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964219 | ZIP CONDOM CATHETER | Goulter Medical, Inc. | 1997-08-11 |
| K961906 | UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 | Spectrum Medsystems Corp. | 1996-11-19 |
| K952780 | URINARY GEL DRAINAGE SYSTEM | P.A.M., Inc. | 1995-12-12 |
| K951597 | URINARY DRAINAGE BAG | Key Medical Services, Inc. | 1995-08-04 |
| K942753 | ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER | Researched, Novel Medical Devices (Rn/Md) | 1994-11-02 |
| K933126 | COMFORTCARE SYSTEM | Patsy J. Trisler, J.D. | 1994-02-25 |
| K930556 | NIGHT URINARY DRAINAGE BEDSIDE BAG | Ezmt Valve Co., Inc. | 1993-05-14 |
| K896695 | DYNA-FLO URINARY DRAINAGE BAG | Medline Industries, Inc. | 1990-05-02 |
| K901000 | URO TEX URINALS | Sierra Laboratories, Inc. | 1990-03-26 |
| K890465 | CLOSED SYSTEM URINARY DRAINAGE BAG | Cypress Medical Products, Ltd. | 1989-05-23 |
| K891178 | TECNOL SECURE-ALL TUBE HOLDER | Tecnol New Jersey Wound Care, Inc. | 1989-05-23 |
| K882714 | URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 | Lsl Industries, Inc. | 1989-01-31 |
| K780267 | CATH TRAY W/OUT CATHETER | Latex Ind., Inc. | 1978-02-24 |
| K772113 | URINARY DRAINAGE BAG 2D9017 | Travenol Laboratories, S.A. | 1977-11-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840118611930 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-14 |
| 00840118607346 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-14 |
| 20610075105612 | Hollister | HOLLISTER INCORPORATED | 2022-12-01 |
| 20610075096552 | Hollister | HOLLISTER INCORPORATED | 2022-12-01 |
| 20610075096453 | Hollister | HOLLISTER INCORPORATED | 2022-12-01 |
| 20610075093469 | Hollister | HOLLISTER INCORPORATED | 2022-12-01 |
| 00610075105618 | Hollister | HOLLISTER INCORPORATED | 2022-12-01 |
| 00610075096558 | Hollister | HOLLISTER INCORPORATED | 2022-12-01 |
| 00610075096459 | Hollister | HOLLISTER INCORPORATED | 2022-12-01 |
| 10080196028863 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-01-16 |
| 36641670005589 | SmartTap™ Paracentesis Drainage Bag, 4L | Cardiomed Supplies Inc | 2020-11-27 |
| 16641670005615 | SmartTap™ Paracentesis Drainage Bag, 2L | Cardiomed Supplies Inc | 2020-11-27 |
| 16641670005578 | SmartTap™ Paracentesis Drainage Bag, 4L | Cardiomed Supplies Inc | 2020-11-27 |
| 36641670005626 | SmartTap™ Paracentesis Drainage Bag, 2L | Cardiomed Supplies Inc | 2020-11-27 |
| 05055788767459 | EZ-Flow Catheter Valve | FLEXICARE MEDICAL LIMITED | 2020-03-25 |
| 10884521003453 | Dover | Cardinal Health, Inc. | 2018-06-27 |
| 10884521003446 | Dover | Cardinal Health, Inc. | 2018-06-27 |
| 20884521003443 | Dover | Cardinal Health, Inc. | 2018-06-27 |
| 20884521003450 | Dover | Cardinal Health, Inc. | 2018-06-27 |
| 10080196183531 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196183418 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196183401 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196183012 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196028856 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 40080196028857 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 40080196183013 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 40080196183402 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196028825 | Medline | MEDLINE INDUSTRIES, INC. | 2016-09-29 |
| 10080196028832 | Medline | MEDLINE INDUSTRIES, INC. | 2016-09-29 |
| 10080196028894 | Medline | MEDLINE INDUSTRIES, INC. | 2016-09-29 |