Data / Medical devices / Tracheotomy Care Kit

Tracheotomy Care Kit (NXA): 15 FDA-registered makers in 4 countries

Name: FDA-registered makers of Tracheotomy Care Kit
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

15 establishments in 4 countries are registered with the FDA to make Tracheotomy Care Kit (product code NXA, Class 2, 21 CFR 868.5800). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 18, 1985, and lists 11 recall events (3 Class I). FDA data exported November 2, 2026.

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Product code: NXA
Device class: 2
Regulation: 868.5800
Medical specialty: Anesthesiology

Makers by country

Country	Makers
United States	7
Mexico	5
China	2
Honduras	1

Makers of Tracheotomy Care Kit

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	Class I	Source
Busse Hospital Disposables	Hauppauge, NY, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	1	1	api.fda.gov
Cardinal Health 200, LLC	El Paso, TX, United States	Manufacturer	0	0	api.fda.gov
Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, Mexico	Manufacturer	0	0	api.fda.gov
Honduras Kitting, S.A.	Villanueva Cortes, Honduras	Contract manufacturer	0	0	api.fda.gov
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan City Hubei, China	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Invenio Alternate Care Solutions, LLC	Peachtree Corners, GA, United States	Contract manufacturer	0	0	api.fda.gov
Medical Action Industries, Inc. 306	Arden, NC, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0	0	api.fda.gov
MEDLINE INDUSTRIES, LP - Laredo	Laredo, TX, United States	Manufacturer	0	0	api.fda.gov
Medline Industries, LP - SPT	Waukegan, IL, United States	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, Mexico	Contract sterilizer, Manufacturer	0	0	api.fda.gov
Medline Soluciones Medicas	Nuevo Laredo Tamaulipas, Mexico	Manufacturer	0	0	api.fda.gov
Productos Medline S.A. De C.V.	NUEVO LAREDO Tamaulipas, Mexico	Manufacturer	0	0	api.fda.gov
Taizhou Xinkang Medical Materials Co., Ltd	Taizhou Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.	MEXICALI Baja California, Mexico	Manufacturer, Repackager or relabeler	0	0	api.fda.gov
Trinity Sterile, Inc.	Salisbury, MD, United States	Manufacturer	0	0	api.fda.gov

Updated January 18, 1985. 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.