Data / Medical devices / United States / Reliable Healthcare Logistics, LLC
Reliable Healthcare Logistics, LLC: FDA-registered device maker in Dayton, NJ, United States, 2 510(k) clearances
Reliable Healthcare Logistics, LLC is registered with the FDA (registration 3027592507) in Dayton, NJ, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 24, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027592507
- Address
- 6 Wheeling Rd Suite A, Dayton, NJ, United States, 08810
- Owner or operator
- Reliable Healthcare Logistics, LLC (10086675)
- Roles
- Repackager or relabeler
- First device listed
- October 12, 2023
- Registered through
- 2026
- Brand names listed
- NIPRO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 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 |
|---|---|---|---|---|---|---|
| February 24, 2020 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| February 8, 2017 | K160444 | FB-U Hemodialyzer | KDI | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Updated February 24, 2020. 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.