System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Gastroenterology, Urology · 21 CFR 876.5250
Recent MDR events
44 adverse event reports on file
- PENROSE DRAINOct 14, 2021InjuryMedline Industries, Lp - NorthfieldMW5104645
- DRAIN, PENROSEJan 27, 2016InjuryMedline Industries, Inc.1417592-2016-00006
- PECO TOUCH-FREE CATHETERIZATION SYSTEMOct 13, 2014MalfunctionPeco Medical, Inc.MW5038594
- KENDALLDec 30, 2009MalfunctionCovidien1569909
- KENDALLJul 23, 2008MalfunctionTyco Healthcare GroupMW5007783
- AMS 800 URINARY CONTROL SYSTEMJan 31, 2007American Medical SystemsMW4004275
- DISPOZ-A-BAGSep 8, 2006Bard Access Systems778851
- KENDALLAug 8, 2006OtherTyco Healthcare/kendall9612030-2006-00030
- DISPOZ-A-BAGJul 6, 2006MalfunctionBard Access Systems733483
- MONOFLO DRAINAGE BAGJun 5, 2006Kendall734299
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
50 firms currently registered for this product code
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Sterigenics Us Llc
Grand Prairie, TX, US
Shaoxing Jiancheng Medical Products Co., Ltd.
Shaoxing Zhejiang, CN
Guangzhou Four E's Scientific Co., Ltd.
GUANGZHOU Guangdong, CN
Sterigenics Shanghai Eto Ltd.
Shanghai, CN
Sterigenics U.s., Llc
Charlotte, NC, US
Huaian Angel Medical Instrument Co., Ltd
Huaian Jiangsu, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Rece International Corp.
Miami, FL, US
Ningbo Yingmed Medical Instruments Co.,ltd.
Ningbo Zhejiang, CN
Bonree Medical Co., Ltd
Zhongshan Guangdong, CN
Isomedix Operations Inc.
SAN DIEGO, CA, US
Ningbo Risenmed Technology Co.,ltd.
Ningbo Zhejiang, CN
Hollister, Inc.
Mount Juliet, TN, US
Djo, Llc
Carlsbad, CA, US
Amis (xiamen) Cultural Creativity Co., Ltd
Xiamen Fujian, CN
Biotronix Healthcare Industries Inc.
Orlando, FL, US
Lsl Healthcare
Niles, IL, US
Hollister Incorporated
LIBERTYVILLE, IL, US
Cardinal Health
Hazelwood, MO, US
Suzhou Virgil Medical Technology Co., Ltd.
suzhou Jiangsu, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Hangzhou Fushan Medical Appliance Co., Ltd.
Hangzhou City Zhejiang, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
510(k) clearances
14 clearances for this product code
- Goulter Medical, Inc.Aug 11, 1997
K964219 · ZIP CONDOM CATHETER
- Spectrum Medsystems Corp.Nov 19, 1996
K961906 · UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018
- P.A.M., Inc.Dec 12, 1995
K952780 · URINARY GEL DRAINAGE SYSTEM
- Key Medical Services, Inc.Aug 4, 1995
K951597 · URINARY DRAINAGE BAG
- Researched, Novel Medical Devices (Rn/Md)Nov 2, 1994
K942753 · ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER
- Patsy J. Trisler, J.D.Feb 25, 1994
K933126 · COMFORTCARE SYSTEM
- Ezmt Valve Co., Inc.May 14, 1993
K930556 · NIGHT URINARY DRAINAGE BEDSIDE BAG
- Medline Industries, Inc.May 2, 1990
K896695 · DYNA-FLO URINARY DRAINAGE BAG