Data / Medical devices / Gauge, Gas Pressure, Cylinder/Pipeline
Gauge, Gas Pressure, Cylinder/Pipeline (BXH): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Gauge, Gas Pressure, Cylinder/Pipeline (product code BXH, Class 1, 21 CFR 868.2610). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on July 27, 1994, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- BXH
- Device class
- 1
- Regulation
- 868.2610
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Taiwan | 2 |
| China | 2 |
| India | 2 |
| New Zealand | 1 |
| Turkey | 1 |
Makers of Gauge, Gas Pressure, Cylinder/Pipeline
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 |
|---|---|---|---|---|---|---|---|---|
| Accutron, Inc. | Phoenix, AZ, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Create Biotech Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 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 | |
| Gentec (shanghai) Corporation | Shanghai, China | 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 | |
| Megasan Medikal Gaz Sistemleri Tibbi Alet Ve Cihazlar San. Tic. A. S. | Cankiri, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MPS Project | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Fluidics Division Parker Hannifin Corp. | Hatfield, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ruian Sunnyworld International Trade Co.,ltd | RUIAN Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 27, 1994. 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.