Data / Medical devices / United States / Om Healthcare Logistics Om03
Om Healthcare Logistics Om03: FDA-registered device maker in Louisville, KY, United States, 2 510(k) clearances
Om Healthcare Logistics Om03 is registered with the FDA (registration 3008135745) in Louisville, KY, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 21, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008135745
- Address
- 6201 Global Distribution Way Ste 101, Louisville, KY, United States, 40228
- Owner or operator
- O & M Halyard, Inc. (10039033)
- Roles
- Repackager or relabeler
- First device listed
- September 30, 2022
- Registered through
- 2026
- Brand names listed
- sterilization Wrap
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | 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 |
|---|---|---|---|---|---|---|
| March 21, 2016 | K153554 | Genesis Low Temperature Reusable Rigid Container System | KCT | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
| January 8, 2015 | K142529 | Genesis Reusable Rigid Container System | KCT | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 21, 2016. 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.