CitraPure D5-112

GUDID 00814963021084

ROCKWELL MEDICAL, INC.

Haemodialysis concentrate
Primary Device ID00814963021084
NIH Device Record Key0d346059-f764-4e15-88c7-1f9751b969c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCitraPure
Version Model NumberD5-112
Catalog NumberD5-112
Company DUNS933721433
Company NameROCKWELL MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814963021084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-18

On-Brand Devices [CitraPure]

00814963021428L4-135-55
00814963021411L4-135
00814963021299L4-044C-55
00814963021282L4-033C-55
10814963021272L4-066C
10814963021265L4-055C
00814963021251L4-044C
10814963021241L4-033C
10814963021234L4-022C
10814963021227L4-011C
00814963021213D4-044C
00814963021206D4-033C
00814963021183D4-134
10814963021173L3-145
10814963021166L3-134
00814963021152L3-132W
00814963021138D5-170
00814963021107D5-110
00814963021091D4-133
00814963021084D5-112
00814963021077D4-128
00814963021060D4-126
00814963021053D4-124
00814963021046D4-117
00814963021039D4-116
00814963021022D4-110
00814963021015L4-216
00814963020995D4-114
00814963020988D4-108
00814963020971D4-103
00814963020964D3-145
00814963020957D3-140
00814963020940D3-134
00814963020933D3-130
00814963020926L4-126
00814963020919L4-125-55
00814963020902L4-124-55
00814963020889L4-117-55
00814963020872L4-117
00814963020865L4-116-55
00814963020858L4-116
00814963020841L4-114-55
00814963020834L4-110-55
00814963020827L4-126-55
00814963020810L4-114
00814963020803L4-110
00814963020797L4-108-55
00814963020780L4-108
00814963020773L4-107-55
00814963020766L4-107

Trademark Results [CitraPure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CITRAPURE
CITRAPURE
97106110 not registered Live/Pending
Kerry Luxembourg S.à.r.l.
2021-11-03
CITRAPURE
CITRAPURE
78885375 3851758 Live/Registered
ROCKWELL MEDICAL, INC.
2006-05-17
CITRAPURE
CITRAPURE
77058863 3701950 Live/Registered
KERRY LUXEMBOURG S.À.R.L.
2006-12-07

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