BICARB, DUAL, 100, MIX/DEL, SP EQASSY100BC-2TNK-SP

GUDID BC0011

Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications. Short profile height.

BETTER WATER, LLC

Haemodialysis system bicarbonate mixer
Primary Device IDBC0011
NIH Device Record Keydda5249c-c5f3-4338-9011-f385e9792f7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBICARB, DUAL, 100, MIX/DEL, SP
Version Model NumberEQASSY100BC-2TNK-SP
Catalog NumberEQASSY100BC-2TNK-SP
Company DUNS055252159
Company NameBETTER WATER, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCBC0011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FINTank, Holding, Dialysis

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 Date2016-10-13

Devices Manufactured by BETTER WATER, LLC

PR0011 - MATRIX -PRETREAT, 1", 230V, CPVC2019-07-08 Pretreatment rack with HIM (touch-screen) and blend valve. 1" piping, pump, CPVC, 230V.
PR0012 - MATRIX-PRETREAT, 1" 208V, CPVC2019-07-08 Pretreatment rack with HIM (touch-screen) and blend valve. 1" piping, pump, CPVC, 208V.
PR0013 - MATRIX-PRETREAT, 1.5", 230V, CPVC2019-07-08 Pretreatment rack with HIM (touch-screen) and blend valve. 1.5" piping, pump, CPVC, 230V.
PR0014 - MATRIX-PRETREAT, 1.5", 208V, CPVC2019-07-08 Pretreatment rack with HIM (touch-screen) and blend valve. 1.5" piping, pump, CPVC, 208V.
BC0001 - BICARB, DUAL, 100, MIX/DEL2018-07-06 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications.
BC0002 - BICARB, DUAL, 100, MIX/DEL/10002018-07-06 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications, with large pump for longer
BC0011 - BICARB, DUAL, 100, MIX/DEL, SP2018-07-06Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications. Short profile height.
BC0011 - BICARB, DUAL, 100, MIX/DEL, SP2018-07-06 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications. Short profile height.
BC0012 - BICARB, DUAL, 100, MIX/DEL/1000, SP2018-07-06 Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications, with large pump for longer
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