MD440 Reverse Osmosis System

FDA UDI

Class II (US FDA UDI)

by Isopure, Corp.

Identity

Trade Name: MD440 Reverse Osmosis System FDA UDI
Generic Name: Reverse-osmosis water purification system FDA UDI
Device Name: MD440 Reverse Osmosis System FDA UDI
Model / Reference: MD440 FDA UDI
Description: MD440 Reverse Osmosis System FDA UDI

Identifiers

Primary DI / UDI-DI: 00852456007016 FDA UDI
510(k) Number: K993200 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

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

Yes

FDA UDI

Category: Reverse-osmosis water purification system

MD440 Reverse Osmosis System by Isopure, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K993200 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: Isopure, Corp.

Sources (1)

FDA UDI b43b1c53-edac-4a1e-97cb-ce341df4cb28 34 fields · synced May 30, 2026