Data / Medical devices / Saline, Vascular Access Flush
Saline, Vascular Access Flush (NGT): 26 FDA-registered makers in 9 countries
26 establishments in 9 countries are registered with the FDA to make Saline, Vascular Access Flush (product code NGT, Class 2, 21 CFR 880.5200). 18 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on December 2, 2025, and lists 30 recall events (6 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
- NGT
- Device class
- 2
- Regulation
- 880.5200
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| China | 7 |
| Canada | 1 |
| Spain | 1 |
| Italy | 1 |
| Indonesia | 1 |
| India | 1 |
| South Korea | 1 |
| Mexico | 1 |
Makers of Saline, Vascular Access Flush
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 |
|---|---|---|---|---|---|---|---|---|
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 5 | December 2, 2025 | 0 | 4 | 0 | api.fda.gov |
| Medefil, Inc. | Glendale Heights, IL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 4 | September 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Medxl Inc | Pointe-Claire Quebec, Canada | Manufacturer | 4 | February 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Aquabiliti | Nashville, TN, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 3 | August 13, 2014 | 0 | 5 | 0 | api.fda.gov |
| Becton Dickinson, S.A. | FRAGA Huesca, Spain | Manufacturer | 3 | December 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Excelsior Medical LLC | Neptune, NJ, United States | Manufacturer | 3 | September 15, 2019 | 0 | 3 | 0 | api.fda.gov |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Manufacturer, Specification developer | 2 | March 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson And Company | Columbus, NE, United States | Manufacturer | 2 | February 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nurse Assist, LLC | Haltom City, TX, United States | Manufacturer | 2 | August 11, 2020 | 0 | 2 | 2 | api.fda.gov |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang Anhui, China | Manufacturer | 1 | August 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Anhui Tianyang Pharmaceutical Co., Ltd | Tianchang Anhui, China | Manufacturer | 1 | August 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Excelsior Medical LLC | Tinton Falls, NJ, United States | Manufacturer | 1 | June 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Hantech Medical Device Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 1 | September 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries, LP - ReadyCare Hartland | Hartland, WI, United States | Manufacturer | 1 | June 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Pentaferte Italia S.R.L. | CAMPLI Teramo, Italy | Manufacturer | 1 | July 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| PT Oneject Indonesia | Kab Bekasi Jawa Barat, Indonesia | Manufacturer, Specification developer | 1 | September 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Spectra Medical Devices, LLC | Wilmington, MA, United States | Specification developer | 1 | July 29, 2011 | 0 | 1 | 1 | api.fda.gov |
| SPM Medicare Pvt, Ltd. | NOIDA Uttar Pradesh, India | Manufacturer | 1 | November 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CLAYENS Crystal Lake, LLC | Crystal Lake, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hantech (ningbo) Medical Technology Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huons Co., Ltd. | Jecheon-si Chungbuk, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiaxing Tianhe Pharmaceutical Co., Ltd. | Jiaxing Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinan Babio Biotechnology Co.,ltd. | Jinan City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices Mexico LLC | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Piccolo Medical | San Francisco, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 2, 2025. 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.