AmeriWater MRO3

FDA UDI

Class II (US FDA UDI)

by Ameriwater Llc.

Identity

Trade Name: AmeriWater MRO3 FDA UDI
Generic Name: Reverse-osmosis water purification system FDA UDI
Device Name: MRO3, 3 Membrane Central RO, 4,200 GPD, 230V 1Ph; 208V, 230V, or 460V 3Ph FDA UDI
Model / Reference: MRO3 FDA UDI
Description: MRO3, 3 Membrane Central RO, 4,200 GPD, 230V 1Ph; 208V, 230V, or 460V 3Ph FDA UDI

Identifiers

Primary DI / UDI-DI: 00817927020222 FDA UDI
510(k) Number: K991519 FDA UDI
FDA Product Code: FIP FDA UDI
GMDN Term: Reverse-osmosis water purification system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5665 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 217 Pound FDA UDI
Depth — 18.5 Inch FDA UDI
Width — 18.5 Inch FDA UDI
Height — 52 Inch FDA UDI

Category: Reverse-osmosis water purification system

AmeriWater MRO3 by Ameriwater Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Reverse-osmosis water purification system.

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AquaA — VIVONIC GmbH · Class II
BioPure 4400 RO — MAR COR PURIFICATION, INC. · Class II
BioPure 4400 RO — MAR COR PURIFICATION, INC. · Class II
BioPure HX2 — Biolab Equipment Ltd · Class II

Cleared under the same submission

K991519 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ameriwater Llc.

Sources (1)

FDA UDI f61edd71-c4eb-41e8-be05-572bf51e5006 35 fields · synced May 30, 2026