Data / Medical devices / Container, Specimen Mailer And Storage, Temperature Controlled, Sterile / United States
FDA-registered makers of Container, Specimen Mailer And Storage, Temperature Controlled, Sterile in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Container, Specimen Mailer And Storage, Temperature Controlled, Sterile (product code KDW). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
- Product code
- KDW
- Country
- United States
Makers of Container, Specimen Mailer And Storage, Temperature Controlled, Sterile in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Covidien | North Haven, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | Ponce, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venture Solutions | Arden Hills, MN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vericel Corporation | Cambridge, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.