Data / Medical devices / Support, Breathing Tube
Support, Breathing Tube (JAY): 61 FDA-registered makers in 17 countries
61 establishments in 17 countries are registered with the FDA to make Support, Breathing Tube (product code JAY, Class 1, 21 CFR 868.5280). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on January 27, 1995, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- JAY
- Device class
- 1
- Regulation
- 868.5280
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 19 |
| China | 13 |
| Mexico | 7 |
| Germany | 5 |
| Canada | 2 |
| United Kingdom | 2 |
| Pakistan | 2 |
| South Korea | 2 |
| Switzerland | 1 |
| New Zealand | 1 |
| Israel | 1 |
| Taiwan | 1 |
| Thailand | 1 |
| India | 1 |
| Turkey | 1 |
| Australia | 1 |
| Lithuania | 1 |
Makers of Support, Breathing Tube
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 | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| B & B Medical Technologies, Inc. | Carlsbad, CA, United States | Specification developer | 1 | October 20, 1987 | 0 | 0 | 0 | api.fda.gov |
| Acanthus Medical Creations, LLC | Wauconda, IL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AMTRION GMBH (formerly Haseke & Kroemker) | Porta Westfalica North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - Trenton | TRENTON Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baitella AG | Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bird & Cronin, LLC | Eagan, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brightwake Ltd | Kirkby-in-Ashfield Nottinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Shihui Living Products Ltd. | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Vincent Rehab Devices Company Limited | DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRW Medical | Aston, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flight Medical Innovations Ltd. | PETACH TIKVA Central, Israel | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galemed Corp. | WU-JIA Yilan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Respiratory Solutions, Inc. (dba) Respiralogics | Reno, NV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilbro International (pvt) Limited | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huana Technology (thailand) Co., Ltd. | Bang Pakong Chachoengsao, Thailand | Manufacturer | 0 | 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 | 0 | api.fda.gov | |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 0 | 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 | 0 | api.fda.gov | |
| Inhalation Plastics, Inc. | Pittsburgh, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Industries, Incorporated | Bethel Park, PA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Intersurgical Ltd. | Wokingham, Berkshire, United Kingdom | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IPE Plastic & Hardware Industy, LTD | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jan Mao Industries Co., Ltd. | Guangxi Zhuang Autonomous Region, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L-D Tool & Die Division Of Madix Engineering | Ottawa Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Larynnovation, Inc | La Jolla, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marketlab Incorporated | Caledonia, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marpac, Inc. | Albuquerque, NM, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Devices (pvt) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicaps Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. | Tire Izmir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neotech Products, LLC | Valencia, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Castle Medical Import & Export Co.,ltd | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Chibanda Imp &exp Co, Ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Huakun Medical Equipment Co.,ltd | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novem Medical S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pepper Medical, Inc. | West Chester, PA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pryor Products | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resmed Pty Ltd. | BELLA VISTA New South Wales, Australia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resvent Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S & Mohr America, S.A. DE C.V. | ESTADO DE MEXICO Ciudad de Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sewoon Medical Co., Ltd. | Cheonan-si Chungnam, South Korea | Contract manufacturer, Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Haitech Medical Products Co., Ltd | SHAOXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Avon Textile Co., Ltd. | Suzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tarry Medical Products, Inc. | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | PABRADE Svencionys, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VBM Medizintechnik GMBH | SULZ AM NECKAR Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velcromex, S.A. De C.V. | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W.T. Farley, Inc. | Ladson, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed, Inc. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wilamed GMBH | Kammerstein Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed de Mexico, S.A de C.V | NOGALES Sonora, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 27, 1995. 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.