Data / Medical devices / Mask, Gas, Anesthetic

Mask, Gas, Anesthetic (BSJ): 124 FDA-registered makers in 21 countries

Name: FDA-registered makers of Mask, Gas, Anesthetic
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

124 establishments in 21 countries are registered with the FDA to make Mask, Gas, Anesthetic (product code BSJ, Class 1, 21 CFR 868.5550). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 51 510(k) clearances under this code, the latest on October 13, 2017, and lists 1 recall event (1 Class I). FDA data exported November 2, 2026.

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Product code: BSJ
Device class: 1
Regulation: 868.5550
Medical specialty: Anesthesiology

Makers by country

Country	Makers
China	63
United States	16
Taiwan	11
Mexico	5
United Kingdom	5
Germany	3
India	3
Malaysia	3
Pakistan	2
Australia	2
Italy	1
Vietnam	1
Belarus	1
Finland	1
Denmark	1
Brazil	1
Sweden	1
Canada	1
Turkey	1
Estonia	1
Lithuania	1

Makers of Mask, Gas, Anesthetic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
Covidien	Lafayette, CO, United States	Specification developer	1	August 11, 1995	0	0	api.fda.gov
GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, China	Contract manufacturer, Manufacturer	1	June 7, 1995	0	0	api.fda.gov
Mallinckrodt Dar S.r.l.	MIRANDOLA Modena, Italy	Manufacturer	1	August 11, 1995	0	0	api.fda.gov
Productos Urologos De Mexico S.A. De C.V.	MEXICALI Baja California, Mexico	Manufacturer	1	October 13, 2017	0	0	api.fda.gov
SunMed Group Holdings, LLC	Grand Rapids, MI, United States	Complaint file establishment, Repackager or relabeler, Specification developer	1	October 13, 2017	0	0	api.fda.gov
AMBU Limited	XIANG YU F.T.Z., XIAMEN Fujian, China	Contract manufacturer	0		0	0	api.fda.gov
An Lanh Investment And Trading Company Limited	Thanh Nam Ward Ninh Binh, Vietnam	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Anji Hongde Medical Products Co., Ltd.	HUZHOU Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Anji Spenq Industrial Co., Ltd.	Huzhou Zhejiang, China	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Asia Connection Co., Ltd.	New Taipei City, Taiwan	Contract manufacturer, Exporter to the US	0		0	0	api.fda.gov
Asomedica Co. Ltd	Smolevichi District Minsk, Belarus	Manufacturer	0		0	0	api.fda.gov
AirLife Finland Oy	Helsinki Uusimaa, Finland	Complaint file establishment, Contract manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Ambu A/S	Ballerup Hovedstaden, Denmark	Specification developer	0		0	0	api.fda.gov
Ambu Mexico Operations S.A. DE C.V.	Ciudad Juarez Chihuahua, Mexico	Contract manufacturer	0		0	0	api.fda.gov
Anesthesia Associates, Inc.	San Marcos, CA, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
B. Ali Impex	SIALKOT, Punjab, Pakistan	Manufacturer	0		0	0	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	0		0	0	api.fda.gov
BQ Plus Medical Co.,ltd	SONGJIANG Shanghai, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Besmed Health Business Corporation	New Taipei City, Taiwan	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Changzhou Holymed Products Co., Ltd	CHANGZHOU Jiangsu, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Clement Clarke Intl., Ltd.	Mountain Ash Rhondda Cynon Taff, United Kingdom	Specification developer	0		0	0	api.fda.gov
Create Biotech Co., Ltd.	Taoyuan City, Taiwan	Manufacturer	0		0	0	api.fda.gov
ConvaTec Limited, GDC Building	Deeside Flintshire, United Kingdom	Specification developer	0		0	0	api.fda.gov
Doner Industries, Inc.	Rogers, AR, United States	Specification developer	0		0	0	api.fda.gov
Dongguan City Ruimi Gift Products Co Ltd	Dongguan Guangdong, China	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Draeger Interservices GmbH	Luebeck Schleswig-Holstein, Germany	Contract manufacturer	0		0	0	api.fda.gov
Draegerwerk AG & Co. KGaA	LUEBECK Schleswig-Holstein, Germany	Specification developer	0		0	0	api.fda.gov
Enter Medical Corporation	Chiayi County Chiayi(County), Taiwan	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Evereast Medical Products Group Co., Ltd	Changyuan City Henan, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Excellentcare Medical (Huizhou) Ltd.	Huizhou Guangdong, China	Manufacturer	0		0	0	api.fda.gov
Flexicare Medical (dongguan) Ltd.	DONGGUAN CITY Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
Flexicare Medical Ltd.	RHONDDA CYNON TAFF Wales, United Kingdom	Specification developer	0		0	0	api.fda.gov
Flying Tooling Engineering Limited	Dongguan Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
Foremount Enterprise Co., Ltd.	Taichung City, Taiwan	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Fte Dynamics, LLC	Chino Hills, CA, United States	Specification developer	0		0	0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	0	api.fda.gov
Galemed Corp.	WU-JIA Yilan, Taiwan	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Guangdong Ecan Medical Co,ltd	Guangzhou Guangdong, China	Manufacturer	0		0	0	api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltd	Guangzhou Guangdong, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Guangzhou Shengwei Medical Devices Co., Ltd.	Guangzhou Guangdong, China	Manufacturer	0		0	0	api.fda.gov
Haiyan Kangyuan Medical Instrument Co.,ltd.	JiaXing Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Hangzhou Formed Medical Devices Co., Ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Hangzhou Rollmed Co.,ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Hangzhou Shanyou Medical Equipment Co.,ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Henan Tuoren Medical Device Co., Ltd.	Changyuan Henan, China	Manufacturer	0		0	0	api.fda.gov
Hitec Medical Co., Ltd	Shanghai, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
HONSUN (NANTONG) Co., Ltd.	Nantong Jiangsu, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Hsiner Co., Ltd.	Taichung City, Taiwan	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Hsiner Co., Ltd.	Taichung City, Taiwan	Contract manufacturer, Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Huzhou Junda Industry Co., Ltd.	Anji Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Heuer International (A division of GST Corporation Limited)	NOIDA Uttar Pradesh, India	Foreign private label distributor, Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Hynaut Health Technology Co., LTD.	Qingdao Shandong, China	Manufacturer	0		0	0	api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, Mexico	Manufacturer	0		0	0	api.fda.gov
Iilabco LLC	Brea, CA, United States	Specification developer	0		0	0	api.fda.gov
Injemedic	VINHEDO Sao Paulo, Brazil	Manufacturer	0		0	0	api.fda.gov
Integral Medical Products Co., Ltd.	SHAOXING Zhejiang, China	Contract manufacturer	0		0	0	api.fda.gov
Intersurgical Ltd.	Wokingham, Berkshire, United Kingdom	Exporter to the US, Specification developer	0		0	0	api.fda.gov
Intersurgical Inc.	Indianapolis, IN, United States	Manufacturer	0		1	1	api.fda.gov
Jiangsu Medplus Non-Woven Manufacturer Co.,ltd.	Siyang Jiangsu, China	Manufacturer	0		0	0	api.fda.gov
Jiangxi Glance Medical Equipment Co., Ltd.	Nanchang City Jiangxi, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Jiangxi Yiles Medical Co., Ltd	Nanchang City Jiangxi, China	Manufacturer	0		0	0	api.fda.gov
Koo Medical Equipment (shanghai) Co. Ltd.	Songjiang Shanghai, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Koo (Shanghai) Industries Co., Ltd	Songjiang Shanghai, China	Manufacturer	0		0	0	api.fda.gov
Lamed Private Limited	FARIDABAD Haryana, India	Manufacturer	0		0	0	api.fda.gov
Maquet Critical Care AB	SOLNA Stockholm, Sweden	Manufacturer	0		0	0	api.fda.gov
Med Systems	San Diego, CA, United States	Manufacturer	0		0	0	api.fda.gov
Medical Developments International	Scoresby Victoria, Australia	Manufacturer	0		0	0	api.fda.gov
Meditech Systems Limited	Shaftesbury Dorset, United Kingdom	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	0		0	0	api.fda.gov
Mile High Medical Supplies LLC	Delta, CO, United States	Manufacturer	0		0	0	api.fda.gov
Mercury Medical Enterprises, LLC	Clearwater, FL, United States	Manufacturer	0		0	0	api.fda.gov
Narang Medical, Ltd.	New Delhi, India	Manufacturer	0		0	0	api.fda.gov
Ningbo Besmed Medical Equipment Corp.	NINGBO Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Ningbo Chibanda Imp &exp Co, Ltd	Ningbo Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Ningbo Hanyue Medical Technology Co.,ltd	CIXI CITY Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Ningbo Huakun Medical Equipment Co.,ltd	Cixi Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Ningbo Luke Medical Devices Co., Ltd.	Yuyao Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Ningbo Runmai Medical Technology Co., Ltd.	Cixi Zhejiang, China	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Ningbo Shengyurui Medical Appliance Co.	Ningbo Zhejiang, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.	Ningbo Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Ningbo Xinwell Medical Technology Co., Ltd.	Cixi Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Ningbo Yingmed Medical Instruments Co.,ltd.	Ningbo Zhejiang, China	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Non-Change Enterprise Co., Ltd.	New Taipei City, Taiwan	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Ningbo Great Mountain Medical Instruments Co.,Ltd	Ningbo Zhejiang, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
O-Two Medical Technologies, Inc.	Brampton Ontario, Canada	Manufacturer	0		0	0	api.fda.gov
Omnimate Enterprise Co., Ltd.	Ilan County Yilan, Taiwan	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.	Tuzla Istanbul, Turkey	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.	IPOH Perak, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Pneuma Therapeutics, Inc.	San Marcos, CA, United States	Specification developer	0		0	0	api.fda.gov
Polymed (xiamen) Plastic Industrial Co.,ltd.	XIAMEN Fujian, China	Contract manufacturer	0		0	0	api.fda.gov
Precision Fluidics Division Parker Hannifin Corp.	Hatfield, PA, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Productos Medline S.A. De C.V.	NUEVO LAREDO Tamaulipas, Mexico	Manufacturer	0		0	0	api.fda.gov
RAUMEDIC Estonia AS	Tallinn Harjumaa, Estonia	Contract manufacturer	0		0	0	api.fda.gov
Resmed Pty Ltd.	BELLA VISTA New South Wales, Australia	Manufacturer	0		0	0	api.fda.gov
ResMed Malaysia Operations Sdn Bhd	Senai Johor, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Shandong Jinlai Huanhai Medical Technology Co.,ltd	Yantai Shandong, China	Manufacturer	0		0	0	api.fda.gov
Shaoxing Haitech Medical Products Co., Ltd	SHAOXING Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Shaoxing Reborn Medical Devices Co.,ltd	Shaoxing Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Shaoxing Undis Medical Technology Company Limited	Shaoxing Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Shenzhen Airgle Corporation Limited	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Sunmed Ap, Ltd.	ZHUHAI Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
Shenzhen Vital Signs-KTL Medical Instrument Co Ltd	Shenzhen Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
Thermedia Corporation	Shelton, WA, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Tylenol Medical Instruments Co., Ltd.	Zhongshan Guangdong, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
UAB Intersurgical	PABRADE Svencionys, Lithuania	Contract manufacturer	0		0	0	api.fda.gov
VADI Medical Technology Co., Ltd.	Taoyuan City, Taiwan	Manufacturer	0		0	0	api.fda.gov
VBM Medizintechnik GMBH	SULZ AM NECKAR Baden-Wurttemberg, Germany	Manufacturer	0		0	0	api.fda.gov
Vega Technologies Inc.	Dongguan City Guangdong, China	Manufacturer	0		0	0	api.fda.gov
Welbreath Technology Co.,ltd	baoding Hebei, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Well Lead Medical Co. Ltd	GUANGZHOU Guangdong, China	Manufacturer	0		0	0	api.fda.gov
Well Lead Medical Co. Ltd	GUANGZHOU Guangdong, China	Manufacturer	0		0	0	api.fda.gov
WESTMED de Mexico, S.A de C.V.	Tecate Baja California, Mexico	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Westmed, Inc.	Tucson, AZ, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Wenzhou Celecare Medical lnstruments Co.,Ltd.	wenzhou Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Xiamen Compower Medical Tech. Co., Ltd.	Xiamen Fujian, China	Manufacturer	0		0	0	api.fda.gov
Xiantao Sanda Industrial Co., Ltd	Xiantao Hubei, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Xinmed Sdn. Bhd.	Senai Johor, Malaysia	Manufacturer	0		0	0	api.fda.gov
Xiamen Tianzuo Medical Co., Ltd.	Xiamen Fujian, China	Manufacturer	0		0	0	api.fda.gov
Xiamen Zhiyuan Medical Technology Co., Ltd.	XIAMEN Fujian, China	Manufacturer	0		0	0	api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.	Shaoxing Zhejiang, China	Manufacturer	0		0	0	api.fda.gov
Zhejiang Lidesen Medical Instrument Co., Ltd	Hangzhou Zhejiang, China	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Zhongshan Hongze Medical Technology Co., Ltd.	Zhongshan Guangdong, China	Manufacturer	0		0	0	api.fda.gov
Zhejiang Medtec Medical devices Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	0	api.fda.gov

Updated October 13, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.