AmeriWater Heatsan 00HS575

Basic Information

• Brand Name: AmeriWater Heatsan 00HS575
• Primary DI: 00817927020048
• Version / Model: 00HS575
• Company Name: AMERIWATER, LLC
• Labeler DUNS: 836758342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-05
• Public Version: 5
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 3f6d2e7c-581d-4e1a-b7ee-e279a26639dd

Device Description

Heatsan, 575V, 3 Phase, Heat Disinfection System for Distribution Loops

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62203	Haemodialysis water purification system washer-disinfector (thermal)	An electrically-powered unit intended to heat water and pump the hot water into the ringline/pipeline of a reverse-osmosis haemodialysis water purification system for cleaning and disinfection. It typically consists of a heater, pump, and connectors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817927020048	GS1

Premarket Submissions

Submission Number	Supplement Number
K142285	000

Device Sizes

Type	Value	Unit	Text
Weight	1580	Pound
Height	70	Inch
Depth	35	Inch
Width	28	Inch