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Sign in to claim this brandRockwell Medical
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4051 Freeport Pkwy Ste 100, GRAPEVINE, TX, 76051
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003463852
- DUNS Number
- —
Catalogue (150)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CitraPure | D5-112 | FDA UDI | Class II | Active |
| DriSate | DR-145 | FDA UDI | Class II | Active |
| DriSate | DF-140 | FDA UDI | Class II | Active |
| DriSate | DF-125 | FDA UDI | Class II | Active |
| CitraPure | L3-140W | FDA UDI | Class II | Active |
| RenalPure | C-110 | FDA UDI | Class II | Active |
| RenalPure | R-110-55 | FDA UDI | Class II | Active |
| RenalPure | RB-25-2 | FDA UDI | Class II | Active |
| RenalPure | CB-15-4 | FDA UDI | Class II | Active |
| RenalPure | R-140-55 | FDA UDI | Class II | Active |
| CitraPure | D3-145 | FDA UDI | Class II | Active |
| DriSate | DF-113 | FDA UDI | Class II | Active |
| RenalPure | C-106 | FDA UDI | Class II | Active |
| RenalPure | C-124 | FDA UDI | Class II | Active |
| DriSate | DC-109 | FDA UDI | Class II | Active |
| RenalPure | C-108 | FDA UDI | Class II | Active |
| RenalPure | C-117-55 | FDA UDI | Class II | Active |
| DriSate | DC-117 | FDA UDI | Class II | Active |
| CitraPure | L4-106 | FDA UDI | Class II | Active |
| RenalPure | R-145 | FDA UDI | Class II | Active |
| CitraPure | D3-140 | FDA UDI | Class II | Active |
| CitraPure | L4-110 | FDA UDI | Class II | Active |
| CitraPure | L3-134 | FDA UDI | Class II | Active |
| CitraPure | D4-108 | FDA UDI | Class II | Active |
| CitraPure | L3-145W | FDA UDI | Class II | Active |
| RenalPure | C-114 | FDA UDI | Class II | Active |
| DriSate | DR-230 | FDA UDI | Class II | Active |
| CitraPure | D4-117 | FDA UDI | Class II | Active |
| RenalPure | C-116 | FDA UDI | Class II | Active |
| CitraPure | L4-110-55 | FDA UDI | Class II | Active |
| RenalPure | R-134-55 | FDA UDI | Class II | Active |
| RenalPure | C-126 | FDA UDI | Class II | Active |
| RenalPure | CB-25-2 | FDA UDI | Class II | Active |
| RenalPure | R-115 | FDA UDI | Class II | Active |
| 5% Acetic Acid Solution | R-100 | FDA UDI | Class II | Active |
| RenalPure | C-120 | FDA UDI | Class II | Active |
| RenalPure | R-230 | FDA UDI | Class II | Active |
| Citrapure | L4-135 | FDA UDI | Class II | Active |
| CitraPure | L3-145 | FDA UDI | Class II | Active |
| CitraPure | L4-044C | FDA UDI | Class II | Active |
| RenalPure | C-131-55 | FDA UDI | Class II | Active |
| RenalPure | R-145-55 | FDA UDI | Class II | Active |
| DriSate | DR-250 | FDA UDI | Class II | Active |
| CitraPure | L3-132W | FDA UDI | Class II | Active |
| RenalPure | C-116-55 | FDA UDI | Class II | Active |
| RenalPure | C-124-55 | FDA UDI | Class II | Active |
| RenalPure | C-216 | FDA UDI | Class II | Active |
| RenalPure | RB-15-4 | FDA UDI | Class II | Active |
| RenalPure | R-125 | FDA UDI | Class II | Active |
| Rockwell Medical CitraPure Acid Concetrate | K160847 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 7, 2018 | Z-1869-2018 | — | terminated | A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. |