AmeriWater Heatsan 00HS208

GUDID 00817927020024

Heatsan, 208V, 3 Phase, Heat Disinfection System for Distribution Loops

AMERIWATER, LLC

Haemodialysis water purification system washer/disinfector Haemodialysis water purification system washer/disinfector Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal) Haemodialysis water purification system washer-disinfector (thermal)

Primary Device ID	00817927020024
NIH Device Record Key	f80a52e1-1eac-491d-b45b-dc5b85d1cac8
Commercial Distribution Status	In Commercial Distribution
Brand Name	AmeriWater Heatsan 00HS208
Version Model Number	00HS208
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	false
OTC Over-The-Counter	true

Device Dimensions

Width	28 Inch
Width	28 Inch
Width	28 Inch
Width	28 Inch
Width	28 Inch
Width	28 Inch
Width	28 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch
Weight	1580 Pound
Height	70 Inch
Depth	35 Inch
Width	28 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817927020024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142285

FDA Product Code

FIP	Subsystem, Water Purification

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-01-05

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00817927020024 - AmeriWater Heatsan 00HS208	2018-07-06Heatsan, 208V, 3 Phase, Heat Disinfection System for Distribution Loops
00817927020024 - AmeriWater Heatsan 00HS208	2018-07-06 Heatsan, 208V, 3 Phase, Heat Disinfection System for Distribution Loops
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00817927020055 - AmeriWater 00BC55-55 Bicarb Mix and Distribution System	2018-07-06 Dual Tank Bicarb Mix and Distribution System, 55 Gallon