Data / Medical devices / Device, Gas Generating

Device, Gas Generating (KZJ): 18 FDA-registered makers in 7 countries

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

18 establishments in 7 countries are registered with the FDA to make Device, Gas Generating (product code KZJ, Class 1, 21 CFR 866.2580). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on April 27, 1988, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: KZJ
Device class: 1
Regulation: 866.2580
Medical specialty: Microbiology

Makers by country

Country	Makers
United States	7
China	3
India	3
Mexico	2
South Korea	1
Japan	1
United Kingdom	1

Makers of Device, Gas Generating

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	Recall events	Source
Advanced Instruments, LLC	Norwood, MA, United States	Manufacturer	0	api.fda.gov
Airgas Therapeutics LLC	Plumsteadville, PA, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Becton Dickinson Caribe Ltd.	Cayey, PR, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Specification developer	3	api.fda.gov
Hue Light Co., Ltd	Gwangmyeong-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Infitek Co., Ltd.	Shanghai, China	Manufacturer	0	api.fda.gov
James Alexander Corp.	Blairstown, NJ, United States	Contract manufacturer	0	api.fda.gov
K&R Technologies Dba Microbiology International	Frederick, MD, United States	Specification developer	0	api.fda.gov
Labpeak Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Mark Enterprises	Nashik Maharashtra, India	Manufacturer	0	api.fda.gov
Marken Healthtech Limited	NASHIK Maharashtra, India	Manufacturer	0	api.fda.gov
Mitsubishi Gas Chemical Co., Inc.	CHIYODA-KU Tokyo, Japan	Manufacturer	0	api.fda.gov
Nalge Nunc International Corporation	Rochester, NY, United States	Contract manufacturer	0	api.fda.gov
Oxoid, Ltd.	Basingstoke, Hampshire, United Kingdom	Exporter to the US, Specification developer	0	api.fda.gov
P Bhogilal Pvt Ltd	Kolkata West Bengal, India	Manufacturer	0	api.fda.gov
RR Donnelley Global Turnkey Solutions	Juarez Chihuahua, Mexico	Contract manufacturer, Repackager or relabeler	0	api.fda.gov
Scitek Global Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Thermo Fisher Scientific (Monterrey)	Apodaca Nuevo Leon, Mexico	Contract manufacturer	0	api.fda.gov

Updated April 27, 1988. 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.