AmeriWater 00BCMD100

GUDID 00817927020314

00BCMD100 Single Tank Mix and Distribution Bicarb, 100 Gallon

AMERIWATER, LLC

Haemodialysis system bicarbonate mixer
Primary Device ID00817927020314
NIH Device Record Keya661d587-0902-4f31-a019-8bf431e9bf28
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmeriWater 00BCMD100
Version Model Number00BCMD100
Company DUNS836758342
Company NameAMERIWATER, 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 Dimensions

Width49 Inch
Width49 Inch
Width49 Inch
Width49 Inch
Width49 Inch
Width49 Inch
Width49 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch
Weight195 Pound
Height59 Inch
Depth36 Inch
Width49 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100817927020314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FINTank, Holding, Dialysis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


[00817927020314]

High-level Disinfectant;Liquid Chemical


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-10

Devices Manufactured by AMERIWATER, LLC

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00817927020338 - AmeriWater Water Purification System for Hemodialysis2023-06-15 AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended t
00817927020000 - AmeriWater MROS2018-07-06 MROS, Single Patient Portable RO, 730 GPD, 115V
00817927020017 - AmeriWater MRO12018-07-06 MRO1 (1 to 2 Stations Portable RO), 1,400 GPD, 115V
00817927020024 - AmeriWater Heatsan 00HS2082018-07-06 Heatsan, 208V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020031 - AmeriWater Heatsan 00HS4602018-07-06 Heatsan, 460V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020048 - AmeriWater Heatsan 00HS5752018-07-06 Heatsan, 575V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020055 - AmeriWater 00BC55-55 Bicarb Mix and Distribution System2018-07-06 Dual Tank Bicarb Mix and Distribution System, 55 Gallon

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