Data / Medical devices / Administration Set Securement Device
Administration Set Securement Device (PUK): 15 FDA-registered makers in 5 countries
15 establishments in 5 countries are registered with the FDA to make Administration Set Securement Device (product code PUK, Class 1, 21 CFR 880.5210). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 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
- PUK
- Device class
- 1
- Regulation
- 880.5210
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Israel | 2 |
| Costa Rica | 1 |
| China | 1 |
| Dominican Republic | 1 |
Makers of Administration Set Securement Device
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 |
|---|---|---|---|---|---|---|---|---|
| ATL Technology CR Limitada | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Calexa, LLC | Gaithersburg, MD, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dale Medical Products, Inc. | New London, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Equashield Medical Ltd | Tefen Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Equashield Medical Ltd | Migdal Tefen Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabriteq | Knoxville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextech, Inc. | Saint Louis Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Jianaian Plastics Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medsorb Dominicana, S.A. | San Pedro De Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nursetech Medical | Colorado Springs, CO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quest Medical, Inc. | Allen, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roddymedical Holdings Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TNT Moborg Intl. Ltd. | Williamsville, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weslacova | North Wilkesboro, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.