50% Citric Acid Solution CAC-100

GUDID 00814963021114

ROCKWELL MEDICAL, INC.

Haemodialysis concentrate
Primary Device ID00814963021114
NIH Device Record Key8173280a-a389-45a8-93c5-8de5f212bb7c
Commercial Distribution StatusIn Commercial Distribution
Brand Name50% Citric Acid Solution
Version Model NumberCAC-100
Catalog NumberCAC-100
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
GS100814963021114 [Primary]
GS110814963021111 [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

Devices Manufactured by ROCKWELL MEDICAL, INC.

10814963020732 - CitraPure2024-04-26
10814963021487 - RenalPure2019-06-25
00814963020001 - Sterilyte2018-07-06
00814963020018 - Sterilyte2018-07-06
00814963020025 - RenalPure2018-07-06
00814963020032 - RenalPure2018-07-06
00814963020049 - RenalPure2018-07-06
00814963020056 - RenalPure2018-07-06

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