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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.

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Product code
NGT
Device class
2
Regulation
880.5200
Medical specialty
General Hospital

Makers by country

CountryMakers
United States12
China7
Canada1
Spain1
Italy1
Indonesia1
India1
South Korea1
Mexico1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Becton DickinsonFranklin Lakes, NJ, United StatesSpecification developer5December 2, 2025040api.fda.gov
Medefil, Inc.Glendale Heights, IL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler4September 20, 2012000api.fda.gov
Medxl IncPointe-Claire Quebec, CanadaManufacturer4February 27, 2024000api.fda.gov
AquabilitiNashville, TN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer3August 13, 2014050api.fda.gov
Becton Dickinson, S.A.FRAGA Huesca, SpainManufacturer3December 2, 2025000api.fda.gov
Excelsior Medical LLCNeptune, NJ, United StatesManufacturer3September 15, 2019030api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaManufacturer, Specification developer2March 22, 2022000api.fda.gov
Becton Dickinson And CompanyColumbus, NE, United StatesManufacturer2February 2, 2017000api.fda.gov
Nurse Assist, LLCHaltom City, TX, United StatesManufacturer2August 11, 2020022api.fda.gov
Anhui Tiankang Medical Technology Co., Ltd.Tianchang Anhui, ChinaManufacturer1August 12, 2023000api.fda.gov
Anhui Tianyang Pharmaceutical Co., LtdTianchang Anhui, ChinaManufacturer1August 12, 2023000api.fda.gov
Excelsior Medical LLCTinton Falls, NJ, United StatesManufacturer1June 21, 2018000api.fda.gov
Hantech Medical Device Co., Ltd.Cixi Zhejiang, ChinaManufacturer1September 27, 2023000api.fda.gov
Medline Industries, LP - ReadyCare HartlandHartland, WI, United StatesManufacturer1June 21, 2018000api.fda.gov
Pentaferte Italia S.R.L.CAMPLI Teramo, ItalyManufacturer1July 20, 2022000api.fda.gov
PT Oneject IndonesiaKab Bekasi Jawa Barat, IndonesiaManufacturer, Specification developer1September 15, 2019000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesSpecification developer1July 29, 2011011api.fda.gov
SPM Medicare Pvt, Ltd.NOIDA Uttar Pradesh, IndiaManufacturer1November 9, 2023000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
CLAYENS Crystal Lake, LLCCrystal Lake, IL, United StatesContract manufacturer0000api.fda.gov
Hantech (ningbo) Medical Technology Co., Ltd.Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Huons Co., Ltd.Jecheon-si Chungbuk, South KoreaContract manufacturer0000api.fda.gov
Jiaxing Tianhe Pharmaceutical Co., Ltd.Jiaxing Zhejiang, ChinaContract manufacturer0000api.fda.gov
Jinan Babio Biotechnology Co.,ltd.Jinan City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
NextPhase Medical Devices Mexico LLCTIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Piccolo MedicalSan Francisco, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.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.