AmeriWater MROS

FDA UDI

Class II (US FDA UDI)

by Ameriwater Llc.

Identity

Trade Name: AmeriWater MROS FDA UDI
Generic Name: Reverse-osmosis water purification system FDA UDI
Device Name: MROS, Single Patient Portable RO, 730 GPD, 115V FDA UDI
Model / Reference: MROS FDA UDI
Description: MROS, Single Patient Portable RO, 730 GPD, 115V FDA UDI

Identifiers

Primary DI / UDI-DI: 00817927020000 FDA UDI
510(k) Number: K111740 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 — 135 Pound FDA UDI
Depth — 24 Inch FDA UDI
Width — 17 Inch FDA UDI
Height — 47 Inch FDA UDI

Category: Reverse-osmosis water purification system

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

Similar devices

Also classified as Reverse-osmosis water purification system.

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BioPure HX2 — MAR COR PURIFICATION, INC. · Class II
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Millenium — MAR COR PURIFICATION, INC. · Class II
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

K111740 also covers:

AmeriWater MRO1 — AMERIWATER LLC.

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 8c0a38d8-e28a-4818-ad35-655d07cf0fb7 36 fields · synced May 30, 2026