RenalPure R-230

GUDID 00814963020476

ROCKWELL MEDICAL, INC.

Haemodialysis concentrate
Primary Device ID00814963020476
NIH Device Record Key2c0f8841-af6d-4150-8506-1cf2e4aa50ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameRenalPure
Version Model NumberR-230
Catalog NumberR-230
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
GS100814963020476 [Primary]
GS110814963020473 [Package]
Package: CASE [4 Units]
In Commercial Distribution

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 Date2015-09-22

On-Brand Devices [RenalPure]

10814963021371C-130
10814963021364C-125
10814963021357C-129
10814963021340C-224
10814963021333C-216
00814963021145R-145-55
00814963021008R-140-55
00814963020483R-245
00814963020476R-230
00814963020469R-150-55
00814963020452R-145
00814963020445R-140
00814963020438R-135
00814963020421R-134-55
00814963020414R-134
00814963020407R-115
00814963020391R-125
00814963020384R-115-55
00814963020377R-116-55
00814963020360R-110-55
00814963020353R-110
00814963020346F-220
00814963020339C-132-55
00814963020322C-131-55
00814963020308C-126-55
00814963020292C-126
00814963020285C-125-55
00814963020278C-124-55
00814963020261C-124
00814963020254C-120
00814963020247C-119-55
00814963020230C-117-55
00814963020223C-117
00814963020216C-116-55
00814963020209C-116
00814963020193C-114-55
00814963020186C-114
00814963020179C-112
00814963020162C-110-55
00814963020155C-110
00814963020148C-108-55
00814963020131C-108
00814963020124C-107
00814963020117C-106
00814963020100C-102
00814963020094RB-25-2
00814963020087RB-15-4
00814963020070RB-02-20
00814963020063FB-25-2
00814963020056CB-25-2

Trademark Results [RenalPure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RENALPURE
RENALPURE
76539654 3029776 Live/Registered
ROCKWELL MEDICAL, INC.
2003-08-25

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