Data / Medical devices / United States / Equashield LLC
Equashield LLC: FDA-registered device maker in Port Washington, NY, United States, 3 510(k) clearances
Equashield LLC is registered with the FDA (registration 3008434487) in Port Washington, NY, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008434487
- Address
- 2 Harbor Park Drive, Port Washington, NY, United States, 11050
- Owner or operator
- EQUASHIELD LLC (10041242)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 3, 2017
- Registered through
- 2026
- Brand names listed
- CSTD, CellSHIELD®, Equashield Reconstitution Set, Sampling Kit Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 17, 2023 | K221513 | Equashield Closed System Transfer Device | ONB | Substantially Equivalent | Equashield Medical , Ltd. | accessdata.fda.gov |
| July 3, 2017 | K170706 | Equashield Closed System drug Transfer Device (CSTD) | ONB | Substantially Equivalent | Equashield Medical , Ltd. | accessdata.fda.gov |
| November 5, 2015 | K150219 | Equashield Closed System drug Transfer Device (CSTD) | ONB | Substantially Equivalent | Equashield Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Updated February 17, 2023. 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.