Strap, Head, Gas Mask
Anesthesiology · 21 CFR 868.5560
Recent MDR events
24 adverse event reports on file
- PREMIUM CHIN STRAP LINCAREMar 12, 2021MalfunctionUnkMW5099995
- MARPAC ADJUSTABLE ET TUBE HOLDERSep 8, 2020InjuryMarpac, Inc.MW5096466
- SHOULDER CHAIR HEAD STRAP/CHIN STRAPAug 25, 2020Skytron10447738
- RESMED AIR TOUCH F20May 9, 2019Resmed Corp.MW5086504
- CHIN STRAPJul 17, 2017MalfunctionUnkMW5071089
- AMARA VIEW C PAP MASK SIZE LARGEJun 20, 2017MalfunctionPhilips RespironicsMW5070558
- PURESOM - ADJUSTABLE RUBY CHIN STRAPJun 6, 2016InjuryCarefusion, Inc2031702-2016-00726
- FACE MASK HEAD STRAPApr 1, 2016InjuryKing Systems1824226-2016-00002
- CAREFUSIONJun 11, 2014OtherCarefusion 211, Inc.1424490-2014-00001
- CAREFUSIONMar 28, 2013OtherCarefusion 211, Inc.1424490-2013-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
94 firms currently registered for this product code
Guardmed Healthcare Kh Co., Ltd.
Bati District Takeo, KH
Shenzhen Sany Pioneer Technology Co., Ltd.
Shenzhen Guangdong, CN
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Sunset Healthcare Solutions Central Warehouse
Elgin, IL, US
Foxxmed Ltd
Ilan Yilan, TW
Allied Medical Llc
Earth City, MO, US
Acare Technology Co., Ltd.
New Taipei City, TW
Tops Medical Articles Industries Nantong Inc
Qidong City Jiangsu, CN
Midwest Sterilization Corp.
LAREDO, TX, US
Yasco Enterprise Corp.
Chiayi County, TW
Zoll International Holding B.v.
Elst Gelderland, NL
Vbm Medizintechnik Gmbh
SULZ AM NECKAR Baden-Wurttemberg, DE
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
Flexicare Medical Ltd.
RHONDDA CYNON TAFF Wales, GB
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Teleflex Medical Llc
Morrisville, NC, US
Yangzhou Qionghua Sports Goods Co.,ltd
Yangzhou Jiangsu, CN
Fortune Company Ltd.
Huizhou Guangdong, CN
Resplabs Medical Usa Inc.
Tucson, AZ, US
Maxhealth Corp.
Xizhi District, New Taipei City, TW
Velcromex, S.a. De C.v.
AGUA PRIETA Sonora, MX
Taroko Intl. Co., Ltd.
JEN-TE, TAINAN, TW
Kego Corporation
London Ontario, CA
Foremount Enterprise Co., Ltd.
Taichung City, TW
Jiangxi Junhong Sporting Goods Co., Ltd.
Ta Khmau Kandal, KH
510(k) clearances
6 clearances for this product code
- Vital Signs, Inc.Nov 14, 1994
K944949 · GENERAL ANESTHESIA SYSTEM
- Vital Signs, Inc.Apr 2, 1992
K914335 · STRAP, HEAD, GAS MASK
- Life Design Systems, Inc.Dec 3, 1985
K854537 · HEADSTRAP
- Medipart Jerry AlexanderOct 29, 1985
K853573 · MEDIPART FACE MASK HEADSTRAP MP-9100
- Medovations, Inc.May 9, 1983
K831008 · HEAD STRAP
- Respironics, Inc.Apr 29, 1981
K810991 · HEADSTRAP