Mask, Oxygen, Low Concentration, Venturi
Anesthesiology · 21 CFR 868.5600
Recent MDR events
27 adverse event reports on file
- N/AJul 9, 2026InjurySalter Labs3004748541-2026-00133
- MASK KIT,FIXED VENTURI,ADULTJul 1, 2019MalfunctionTeleflex Medical3004365956-2019-00179
- HUDSON MASK,MULTI-VENT,ADULTApr 1, 2019MalfunctionTeleflex Medical3004365956-2019-00091
- HUDSON MASK KIT,FIXED VENTURI,ADULT,INTLApr 5, 2018MalfunctionTeleflex Medical3004365956-2018-00107
- HUDSON MASK,MULTI-VENT,ADULTOct 31, 2017MalfunctionTeleflex Medical3004365956-2017-00376
- VENTURI MASK KIT ADULTOct 28, 2016MalfunctionUnomedical Sa De Cv9680866-2016-00094
- VENTURI MASK KIT ADULTFeb 25, 2016MalfunctionUnomedical S.a De C.v.9680866-2016-00065
- VENTURI MASK KIT ADULTFeb 25, 2016MalfunctionUnomedical S.a De C.v.9680866-2016-00066
- ADULT OXYGEN MASK WITH TUBING,02 DILUTER JETS (6),OXYGEN TUBE, NEBULIZER HOODNov 5, 2015MalfunctionUnomedical Sa De Cv9680866-2015-31375
- OXYGEN & AEROSOL THERAPYApr 29, 2014MalfunctionConvatec Limited1000317571-2014-00024
Event type breakdown
Recalls
3 recall events for this product code
- Salter Laboratories, Division of Regulatory AffairsTerminatedOct 26, 2011
Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs;
A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
Z-0112-2012 · View FDA record ↗ - Smiths MedicalTerminatedJun 24, 2011
First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA
A sticky substance on the inside and/ or outside of the Mask
Z-2655-2011 · View FDA record ↗ - Smiths MedicalTerminatedJun 24, 2011
Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face Mask)
A sticky substance on the inside and/ or outside of the Mask
Z-2656-2011 · View FDA record ↗
Registered firms
97 firms currently registered for this product code
Create Biotech Co., Ltd.
Taoyuan City, TW
Intersurgical Ltd.
WOKINGHAM, BERKSHIRE, GB
Flexicare Medical Ltd.
RHONDDA CYNON TAFF Wales, GB
Foremount Enterprise Co., Ltd.
Taichung City, TW
Besmed Health Business Corporation
New Taipei City, TW
S & Mohr America, S.a. De C.v.
ESTADO DE MEXICO Ciudad de Mexico, MX
Salter Labs De Mexico De S.a. De C.v.
Chihuahua Mexico, MX
Suru International Pvt Ltd
DAHANU Maharashtra, IN
Shaoxing Jiancheng Medical Products Co., Ltd.
Shaoxing Zhejiang, CN
Evereast Medical Products Group Co., Ltd
Changyuan City Henan, CN
Rece International Corp.
Miami, FL, US
Zhejiang Baite Medical Appliances Co., Ltd.
Huzhou City Zhejiang, CN
Hangzhou Superds Industry Co., Ltd.
Hangzhou City Zhejiang, CN
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.
Shuyang Jiangsu, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Groman Inc.
Coconut Creek, FL, US
Hsiner Co., Ltd.
TAICHUNG CITY, TW
Non-change Enterprise Co., Ltd.
New Taipei City, TW
Ningbo Runmai Medical Technology Co., Ltd.
Cixi Zhejiang, CN
Ningbo Risenmed Technology Co.,ltd.
Ningbo Zhejiang, CN
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Jiangxi Yiles Medical Co., Ltd
Nanchang City Jiangxi, CN
Convatec Limited, Gdc Building
Deeside Flintshire, GB
Intersurgical Medical Apparatus (changzhou) Co., Ltd.
Changzhou City Jiangsu, CN
Fisher & Paykel Healthcare, Ltd.
EAST TAMAKI Auckland, NZ
510(k) clearances
19 clearances for this product code
- Hospitak, Inc.Feb 28, 1996
K955483 · TRACH MASK MODEL (245, 246)
- Flexicare Medical, Ltd.Apr 27, 1995
K951652 · VENTIMASK MK IV
- Dadsun Corp., Ltd.Oct 13, 1989
K894457 · CARNATION TRACHEOSTOMY MASKS
- Dhd Medical Products Div. Diemolding Corp.Mar 20, 1986
K860873 · VENTURI MASK/ADULT & PAEDIATRIC
- Dhd Medical Products Div. Diemolding Corp.Mar 19, 1986
K860874 · VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC
- Ashai Co. , Ltd.Sep 18, 1985
K852618 · OXY-DIAL
- Airlife, Inc.Sep 20, 1983
K832725 · DUAL DIAL VENTURI STYLE MASK
- Airlife, Inc.Aug 3, 1981
K812066 · PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN