AmeriWater 00BCM55

GUDID 00817927020284

00BCM55 Manual Mix and Dispense Bicarb, 55 Gallon

AMERIWATER, LLC

Haemodialysis system bicarbonate mixer

Primary Device ID	00817927020284
NIH Device Record Key	8c0f6a15-c4ce-4366-95e3-c11b7b33234a
Commercial Distribution Status	In Commercial Distribution
Brand Name	AmeriWater 00BCM55
Version Model Number	00BCM55
Company DUNS	836758342
Company Name	AMERIWATER, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	49 Inch
Width	49 Inch
Width	49 Inch
Width	49 Inch
Width	49 Inch
Width	49 Inch
Width	49 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch
Weight	160 Pound
Height	55 Inch
Depth	29 Inch
Width	49 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817927020284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K051031

FDA Product Code

FIN	Tank, Holding, Dialysis

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

[00817927020284]

High-level Disinfectant;Liquid Chemical

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-01-10

Devices Manufactured by AMERIWATER, LLC

00817927020321 - AmeriWater MediQA 00MSP3HF-230	2023-06-15 MediQA, Single Pass, 3 Membrane, up to 23,040 GPD, 208/230V, 3 Ph
00817927020338 - AmeriWater Water Purification System for Hemodialysis	2023-06-15 AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended t
00817927020000 - AmeriWater MROS	2018-07-06 MROS, Single Patient Portable RO, 730 GPD, 115V
00817927020017 - AmeriWater MRO1	2018-07-06 MRO1 (1 to 2 Stations Portable RO), 1,400 GPD, 115V
00817927020024 - AmeriWater Heatsan 00HS208	2018-07-06 Heatsan, 208V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020031 - AmeriWater Heatsan 00HS460	2018-07-06 Heatsan, 460V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020048 - AmeriWater Heatsan 00HS575	2018-07-06 Heatsan, 575V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020055 - AmeriWater 00BC55-55 Bicarb Mix and Distribution System	2018-07-06 Dual Tank Bicarb Mix and Distribution System, 55 Gallon

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