MedicaPure

GUDID 10817411020063

Liquid Acid Concentrate

DIMESOL USA, LLC

Haemodialysis concentrate
Primary Device ID10817411020063
NIH Device Record Keyd968e6ed-c048-4844-ac8e-41fcc8a98252
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedicaPure
Version Model NumberAC-201
Company DUNS069723499
Company NameDIMESOL USA, LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817411020066 [Primary]
GS110817411020063 [Package]
Contains: 00817411020066
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 Date2017-03-23

On-Brand Devices [MedicaPure]

10817411021039Liquid Acid Concentrate
10817411021015Liquid Acid Concentrate
10817411020490Liquid Acid Concentrate
10817411020438Liquid Acid Concentrate
10817411020339Liquid Acid Concentrate
10817411020162Liquid Acid Concentrate
00817411020110Liquid Acid Concentrate
00817411020103Liquid Acid Concentrate
10817411020087Liquid Acid Concentrate
00817411020073Liquid Acid Concentrate
10817411020063Liquid Acid Concentrate
00817411020059Liquid Acid Concentrate
00817411020042Liquid Acid Concentrate

Trademark Results [MedicaPure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDICAPURE
MEDICAPURE
97440239 not registered Live/Pending
NIPRO CORPORATION
2022-06-02

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