Catheter, Retention, Barium Enema With Bag
Gastroenterology, Urology · 21 CFR 876.5980
Recent MDR events
25 adverse event reports on file
- NAJAFeb 11, 2026InjuryChess Medical Inc.3005099803-2026-00562
- ENEMA RING: FLUID COLLECTION DEVICEOct 31, 2023InjuryBracco Diagnostics Inc18038936
- SUPER XL ENEMA SYSTEM - 8925Dec 31, 2020InjuryBracco Diagnostics Inc.2411512-2020-00001
- FLEXI-TIP ROSESep 27, 2019MalfunctionBracco Diagnostics Inc.2411512-2019-00005
- NON LATEX AIR RETENTION TIPDec 22, 2017MalfunctionE-z-em Inc.2411512-2017-00001
- SUPER XL EMPTY ENEMA KITJul 25, 2017MalfunctionE-z-em, Inc.6740151
- SUPER XL ENEMA SYSTEMJun 30, 2017MalfunctionE-z-em, Inc. (bracco Diagnostics)6680242
- SUPER XL ENEMA SYSTEMApr 5, 2017MalfunctionE-z-em Inc.MW5068973
- NON LATEX MILLER AIR TIPAug 21, 2014MalfunctionEzem2411512-2014-00005
- NON LATEX MILLER AIR TIPAug 21, 2014MalfunctionEzem2411512-2014-00004
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
15 firms currently registered for this product code
Boston Scientific Corporation
Marlborough, MA, US
Pama Manufacturing & Sterilization
mirabel Quebec, CA
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Agile Mv
Montreal Quebec, CA
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.
SUZHOU Jiangsu, CN
Suzhou Texnet
Suzhou Jiangsu, CN
Ningbo Greetmed Medical Instruments Co., Ltd.
Ningbo Zhejiang, CN
Covidien
TIJUANA, B.C. Mexico, MX
E-z-em, Inc.
Princeton, NJ, US
Zhejiang Mediunion Healthcare Group Co.,ltd
Ningbo Zhejiang, CN
Wenzhou Zuoyou Medical Technoloyg Co.,ltd.
Wenzhou Zhejiang, CN
Chess Medical Inc.
Montreal Quebec, CA
Medline Industries, Lp - Northfield
Northfield, IL, US
Alger Technology Co., Ltd.
Taichung City, TW
Availmed S.a.de C.v.
Tijuana Baja California, MX
510(k) clearances
6 clearances for this product code
- Chess Medical, Inc.Jun 16, 2023
K223890 · NAJA Gastrointestinal Catheter
- Mmi, Inc.Dec 18, 1991
K905026 · DUAL FLEX NON-LATEX
- E-Z-Em, Inc.Jan 24, 1991
K905574 · SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
- E-Z-Em, Inc.Nov 27, 1990
K904299 · SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
- Lafayette Pharmacal, Inc.Feb 28, 1989
K884379 · MAGLINTE ENTEROCLYSIS CATHETER
- Mac Lee Medical ProductsNov 17, 1987
K872006 · DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF