Protector, Transducer, Dialysis
Gastroenterology, Urology · 21 CFR 876.5820
Recent MDR events
41 adverse event reports on file
- BULK PACK TRANSDUCER PROTECTORNov 7, 2017MalfunctionErika De Reynosa, S.a. De C.v.8030665-2017-00947
- BULK PACK TRANSDUCER PROTECTORNov 7, 2017MalfunctionErika De Reynosa, S.a. De C.v.8030665-2017-00946
- *Oct 7, 2014Nipro Corporation4169164
- NIPRO SET BLOOD TUBING SETNov 16, 2006Malfunction1056186-2006-00011
- NIPRO BLOODLINEOct 25, 2006Nipro Medical Corporation2316883-2006-00002
- NIPRO SET BLOOD TUBING SET FOR HEMODIALYSISMay 22, 2006MalfunctionNipro Medical Corporation1056186-2006-00008
- NIPROAug 15, 2005OtherNipro Medical Corporation.8041145-2005-00001
- NIPROOct 20, 2004InjuryNipro Medical Corporation8041145-2004-00004
- NIPRO SETJul 15, 2004MalfunctionNipro (thailand) Corp. Ltd.8041145-2004-00002
- NIPRO SETJul 8, 2004MalfunctionNipro (thailand) Corp. Ltd.8041145-2004-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
22 firms currently registered for this product code
Isomedix Operations, Inc.
Libertyville, IL, US
Guangzhou Kaiheng K&s Co.,ltd.
Guangzhou Guangdong, CN
Sterigenics Radiation Technologies Canada, Inc
PORT COQUITLAM British Columbia, CA
Fresenius Medical Care Renal Therapies Group, Llc
Waltham, MA, US
Nipro Corporation
Settsu Osaka, JP
Millipore S.a.s
MOLSHEIM Grand Est, FR
Bain Medical Equipment(guangzhou) Co., Ltd.
Guangzhou Guangdong, CN
Sterigenics Us Llc
Grand Prairie, TX, US
Nipro Medical Corporation
Doral, FL, US
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
Medimexico, S. De R.l. De C.v.
TIJUANA Baja California, MX
Vital Healthcare (guangzhou) Co., Ltd.
Guangzhou Guangdong, CN
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
Sterigenics Us, Llc
Lewis Center, OH, US
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Nxstage Medical, Inc.
LAWRENCE, MA, US
Nipro (thailand) Corporation Limited
SENA Phra Nakhon Si Ayutthaya, TH
Molded Products Inc.
HARLAN, IA, US
Erika De Reynosa, S.a. De C.v.
CD, REYNOSA Tamaulipas, MX
Merck Millipore Ltd.
COUNTY CORK Munster, IE
Sterigenics Us Llc
Fort Worth, TX, US
510(k) clearances
35 clearances for this product code
- Bain Medical Equipment (Guangzhou) Co., Ltd.Jun 28, 2024
K240164 · NovaLine SP-C35 Transducer Protector (956007)
- Nipro Medical CorporationFeb 21, 2008
K072988 · NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
- Ofi Biomedica S.P.A.May 24, 2001
K001971 · HEMODIALYSIS TUBING SETS
- Nipro Medical Corp.Apr 27, 2001
K010264 · NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
- Nipro Medical Corp.Dec 5, 2000
K001465 · NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
- Fresenius Medical Care North AmericaDec 1, 2000
K003445 · FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
- Fresenius Medical Care North AmericaJun 7, 2000
K000702 · BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
- Medisystems Corp.Nov 25, 1998
K983076 · MEDISYSTEMS TRANSDUCER PROTECTOR