Dri-Sate DC-112

GUDID 00814963021190

ROCKWELL MEDICAL, INC.

Haemodialysis concentrate
Primary Device ID00814963021190
NIH Device Record Key9c036690-4a80-4f52-81e1-7a00cc42fad3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDri-Sate
Version Model NumberDC-112
Catalog NumberDC-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
GS100814963021190 [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 Date2016-03-14

On-Brand Devices [Dri-Sate]

00814963021329DC-216
00814963021312DF-109
00814963021190DC-112

Trademark Results [Dri-Sate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DRI-SATE
DRI-SATE
77155100 3361727 Live/Registered
ROCKWELL MEDICAL, INC.
2007-04-12
DRI-SATE
DRI-SATE
75462704 2554474 Live/Registered
Rockwell Medical Technologies, Inc.
1998-04-06

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