Device
AmeriWater® Alarm Panel - Base Model & Remote (R/O Alarm, Low Storage Tank, Low Bicarb, Conductivity, Resistivity and Dump Valve)
Manufacturer
AMERIWATER, LLC
AMERIWATER, LLC
Model: 00850253
Catalog: 00850253
DI: 00817927020413
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 (R/O Alarm, Low Storage Tank, Low Bicarb, Conductivity, Resistivity and Dump Valve)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c0942a9e-04e3-4362-a399-e84114f7c2cb
Distribution Status:
In Commercial Distribution
DUNS Number:
836758342
Device Count:
1
DM Exempt:
Yes
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:
00817927020413
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