BiPro Bicarb Mixing/Distribution System

GUDID B285SDSCB2001

MEDICAL SOLUTIONS INTERNATIONAL, INC.

Haemodialysis system bicarbonate mixer
Primary Device IDB285SDSCB2001
NIH Device Record Key7ab54a88-6f49-4042-a62a-90158fde7bb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiPro Bicarb Mixing/Distribution System
Version Model NumberSDS-CB200
Company DUNS926740010
Company NameMEDICAL SOLUTIONS INTERNATIONAL, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB285SDSCB2001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FINTank, Holding, Dialysis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


[B285SDSCB2001]

Hydrogen Peroxide;Ozone


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-30

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