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Data / Medical devices / United States / University Medical Devices

University Medical Devices: FDA-registered device maker in Omaha, NE, United States, 1 510(k) clearance

University Medical Devices is registered with the FDA (registration 3036113190) in Omaha, NE, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 7, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3036113190
Address
3929 Harney St. Suite 2012, Omaha, NE, United States, 68131
Owner or operator
University Medical Devices (10092682)
Roles
Complaint file establishment, Specification developer
First device listed
February 5, 2025
Registered through
2026
Brand names listed
MicroWash Device, MicroWash Specimen Transport Tube

Devices it lists

DeviceProduct codeClassRoleSource
Container, Specimen Mailer And Storage, Non-SterileNNK1Specification developeraccessdata.fda.gov
Pump, Nebulizer, ManualEPN1Specification developeraccessdata.fda.gov
Saline, Vascular Access FlushNGT2Complaint file establishmentaccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 7, 2013K1210500.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGENGTSubstantially EquivalentBecton, Dickinson & COaccessdata.fda.gov

Compare with other makers

Updated February 7, 2013. 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.