Device
AmeriWater® Alarm Panel - Base Model & Remote with Conductivity (R/O Alarm, Low Storage Tank, Low Bicarb, Conductivity Sensor and High Conductivity Alarm)
Manufacturer
AMERIWATER, LLC
Model: 00850251 Catalog: 00850251 DI: 00817927020390 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-08 Current Version: 2026-05-18
Description
AmeriWater® Alarm Panel - Base Model & Remote with Conductivity (R/O Alarm, Low Storage Tank, Low Bicarb, Conductivity Sensor and High Conductivity Alarm)
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: e9538e91-d204-44df-a6bf-5093f8f51a9d
Distribution Status: In Commercial Distribution
DUNS Number: 836758342
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: Yes
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00817927020390
Type: Primary
Issuing Agency: GS1
GMDN
Code: 14437
Name: Reverse-osmosis water purification system
Definition:
An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste.
FDA Product Codes
FIP
Subsystem, Water Purification
Premarket Submissions
Submission Number: K121022
Supplement Number: 000