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Rockwell Medical

US

Last updated September 17, 2026

Information

Country
US
Address
4051 Freeport Pkwy Ste 100, GRAPEVINE, TX, 76051
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3003463852
DUNS Number
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Catalogue (150)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
RenalPure FB-25-2
FDA UDI
Class IIActive
CitraPure D4-110
FDA UDI
Class IIActive
Dri-Sate DC-216
FDA UDI
Class IIActive
CitraPure L4-125-55
FDA UDI
Class IIActive
DriSate DR-130
FDA UDI
Class IIActive
RenalPure C-114-55
FDA UDI
Class IIActive
Dry Bicarb Mixing System BCMIX100
FDA UDI
Class IIActive
CitraPure L4-216
FDA UDI
Class IIActive
CitraPure D4-033C
FDA UDI
Class IIActive
CitraPure L4-114-55
FDA UDI
Class IIActive
CitraPure D3-134
FDA UDI
Class IIActive
Dri-Sate DF-109
FDA UDI
Class IIActive
CitraPure L4-116-55
FDA UDI
Class IIActive
RenalPure C-102
FDA UDI
Class IIActive
RenalPure R-110
FDA UDI
Class IIActive
CitraPure L4-033C
FDA UDI
Class IIActive
RenalPure C-119-55
FDA UDI
Class IIActive
30% Acetic Acid Solution R-300
FDA UDI
Class IIActive
CitraPure L4-066C
FDA UDI
Class IIActive
CitraPure D5-170
FDA UDI
Class IIActive
RenalPure C-126-55
FDA UDI
Class IIActive
DriSate DC-124
FDA UDI
Class IIActive
RenalPure FB-02-20
FDA UDI
Class IIActive
RenalPure C-224
FDA UDI
Class IIActive
CitraPure D4-116
FDA UDI
Class IIActive
DriSate DF-120
FDA UDI
Class IIActive
RenalPure R-116-55
FDA UDI
Class IIActive
RenalPure C-132-55
FDA UDI
Class IIActive
CitraPure D3-130
FDA UDI
Class IIActive
DriSate DF-111
FDA UDI
Class IIActive
CitraPure D4-126
FDA UDI
Class IIActive
CitraPure D4-114
FDA UDI
Class IIActive
CitraPure L4-117-55
FDA UDI
Class IIActive
CitraPure L4-011C
FDA UDI
Class IIActive
RenalPure C-108-55
FDA UDI
Class IIActive
CitraPure D4-134
FDA UDI
Class IIActive
CitraPure L4-108
FDA UDI
Class IIActive
CitraPure D4-124
FDA UDI
Class IIActive
CitraPure L4-124-55
FDA UDI
Class IIActive
RenalPure C-112
FDA UDI
Class IIActive
Citrapure L4-135-55
FDA UDI
Class IIActive
DriSate DC-110
FDA UDI
Class IIActive
DriSate DR-120
FDA UDI
Class IIActive
CitraPure L4-022C
FDA UDI
Class IIActive
CitraPure L4-117
FDA UDI
Class IIActive
Dry Acid Mixing System DAMX45
FDA UDI
Class IIActive
50% Citric Acid Solution CAC-100
FDA UDI
Class IIActive
Sterilyte RL-01
FDA UDI
Class IIActive
CitraPure L4-126
FDA UDI
Class IIActive
CitraPure D4-103
FDA UDI
Class IIActive

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Importers

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Authorities

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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.

DateRecall No.ClassStatusReason
Apr 7, 2018Z-1869-2018—terminated

A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.