Data / Medical devices / Enteral Syringes With Enteral Specific Connectors
Enteral Syringes With Enteral Specific Connectors (PNR): 29 FDA-registered makers in 10 countries
29 establishments in 10 countries are registered with the FDA to make Enteral Syringes With Enteral Specific Connectors (product code PNR, Class 2, 21 CFR 876.5980). 21 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on July 1, 2026, and lists 1 recall event (1 Class I). FDA data exported November 3, 2026.
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- Product code
- PNR
- Device class
- 2
- Regulation
- 876.5980
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 12 |
| United States | 8 |
| Mexico | 2 |
| Singapore | 1 |
| United Kingdom | 1 |
| Italy | 1 |
| Rwanda | 1 |
| Cambodia | 1 |
| Canada | 1 |
| Thailand | 1 |
Makers of Enteral Syringes With Enteral Specific Connectors
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 |
|---|---|---|---|---|---|---|---|---|
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 4 | April 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 3 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| CMT Health Pte. Ltd. | Singapore, Singapore | Exporter to the US, Specification developer | 2 | April 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Norfolk, NE, United States | Manufacturer | 2 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Deland, FL, United States | Manufacturer | 2 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Gbuk Group Limited | Selby North Yorkshire, United Kingdom | Exporter to the US, Specification developer | 2 | August 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medela LLC | Mchenry, IL, United States | Manufacturer, Specification developer | 2 | February 15, 2017 | 0 | 0 | 0 | api.fda.gov |
| Pentaferte Italia S.R.L. | CAMPLI Teramo, Italy | Manufacturer | 2 | February 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shantou Wealy Medical Instrument Co., Ltd. | SHANTOU Guangdong, China | Manufacturer | 2 | August 27, 2021 | 0 | 0 | 0 | api.fda.gov |
| American Health Packaging | Columbus, OH, United States | Complaint file establishment, Reprocessor | 1 | August 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Manufacturer | 1 | March 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Avent S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Manufacturer | 1 | June 17, 2016 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer | 1 | May 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Intl. Medical Industries | Pompano Beach, FL, United States | Manufacturer | 1 | October 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Caina Medical Co., Ltd | Jiangyin Jiangsu, China | Contract manufacturer, Manufacturer | 1 | August 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Kangbao Medical Equipment Co., Ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 1 | November 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Micsafe Medical Technology Co., Ltd | Yancheng Jiangsu, China | Manufacturer | 1 | October 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Tianyi Medical Appliance CO., Ltd. | Ningbo Zhejiang, China | Contract manufacturer, Contract sterilizer, Manufacturer | 1 | April 28, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo Shandong, China | Manufacturer | 1 | September 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| TKMD Rwanda Ltd | Rwamagana, lburasirazuba Eastern Province, Rwanda | Manufacturer | 1 | August 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| VR Medical Technology Co., Ltd. | KUNSHAN Jiangsu, China | Manufacturer | 1 | September 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Aena Medical (jiangsu) Co.,ltd. | Jiangyin City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang Anhui, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Camedical Technology (cambodia) Co., Ltd. | Samraong Takeo, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu Sichuan, China | Contract 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 | |
| Medxl Inc | Pointe-Claire Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianyi Medical (thailand) Co., Ltd. | PLUAKDAENG DISTRICT Rayong, Thailand | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 1, 2026. 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.