Mouthpiece, Breathing
Anesthesiology · 21 CFR 868.5620
Recent MDR events
11 adverse event reports on file
- MICORGARD II FILTERJun 25, 2025MalfunctionJaeger Medical Gmbh9615102-2025-00173
- MICROSPACERMay 11, 2023MalfunctionRespiratory Delivery Systems, IncMW5117490
- BOX,DISPOSABLE MOUTH PIECEJun 21, 2019InjuryVyaire Medical2021710-2019-10388
- ONE WAY VALVESep 2, 2016DeathGe5935417
- IN CHECK DIALMar 9, 2016MalfunctionAlliance Tech Medical, Inc.MW5060842
- ISOLITE PEDIATRIC MOUTHPIECEJan 21, 2015InjuryInnerlite Dba Isolite Systems2032574-2015-00001
- RESPIRONICS, INC.Dec 21, 2010InjuryRespironics, Inc.MW5018690
- VIASYSMar 12, 2010OtherCarefusion2021710-2010-00008
- VOLUMATICSep 14, 1998MalfunctionCourtaulds Packaging1033964-1998-00001
- MOUTHPIECE BAR BLOCKFeb 16, 1996InjuryUnknownMW1008375
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
166 firms currently registered for this product code
Rusun Medical Co., Ltd
Yichun City Jiangxi, CN
Flexicare Medical Ltd.
RHONDDA CYNON TAFF Wales, GB
Guangzhou Homesun Medical Technology Co., Ltd
Guangzhou Guangdong, CN
Forwardontics
San Mateo, CA, US
Hsiner Co., Ltd.
TAICHUNG CITY, TW
Yiwu Ori-power Medtech Co., Ltd.
YIWU Zhejiang, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Besmed Health Business Corporation
New Taipei City, TW
Cnsac Medshop Gmbh
Theilheim Bavaria, DE
Yancheng Trancom First Aid Supplies Industrial Co., Ltd
Yangcheng Jiangsu, CN
Schiller Ag
BAAR Zug, CH
Shaoxing Undis Medical Technology Company Limited
Shaoxing Zhejiang, CN
Respbuy Healthcare
Gurgaon Haryana, IN
Changsha U De Toptech Electronic Technology Co.,ltd
Changsha Hunan, CN
Jiangsu Jumao X-care Medical Equipment Co., Ltd
Danyang Jiangsu, CN
Ningbo Hanyue Medical Technology Co.,ltd
CIXI CITY Zhejiang, CN
Pujiang Jianyu Sanitary Products Company Ltd.
Jinhua Zhejiang, CN
Westmed, Inc.
TUCSON, AZ, US
Ningbo Tianbo First Aid Product Co., Ltd.
Ningbo Zhejiang, CN
Ndd Medizintechnik Ag
ZURICH, CH
Zhejiang Medtec Medical Devices Co., Ltd
Hangzhou Zhejiang, CN
Juntech (jiaxing) Healthcare Materials Co., Ltd.
Nanhu District, Jiaxing Zhejiang, CN
Cbr Enterprise Limited
Hong Kong, HK
Kaesung Co., Ltd.
Bucheon-Si Gyeonggi, KR
Nanchang White Technology Co., Ltd.
Nanchang Jiangxi, CN
510(k) clearances
25 clearances for this product code
- North State Plastics, Inc.Mar 12, 1996
K955657 · NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
- Monaghan Medical Corp.Nov 2, 1994
K944512 · TRUZONE PFM DISPOSABLE MOUTHPIECE
- Diemolding Corp.Jun 23, 1989
K893791 · BREATHING MOUTHPIECE
- Monaghan Medical Corp.Jul 24, 1987
K872037 · AEROCHAMBER
- Medi Nuclear Corp., Inc.Jan 15, 1987
K865093 · SAFE-T-SHIELD MOUTHPIECE
- Boehringer Ingelheim Pharmaceuticals, Inc.Oct 15, 1986
K863049 · INHALATION AID
- Medipart Jerry AlexanderAug 1, 1986
K862788 · MP-4400 MOUTHPIECE-FLANGE SEAL
- Westmark Enterprises, Inc.Oct 29, 1985
K853266 · PLASTIC MOUTH BARRIER HSV-I