Medical Reverse Osmosis

FDA UDI

Class II (US FDA UDI)

by Speciality Water Technology

Identity

Trade Name: Medical Reverse Osmosis FDA UDI
Generic Name: Reverse-osmosis water purification system FDA UDI
Device Name: UPT-580 Medical RO - 8 Membrane - 13.2 gpm Permeate Production FDA UDI
Model / Reference: K-RO-UPT-580 FDA UDI
Description: UPT-580 Medical RO - 8 Membrane - 13.2 gpm Permeate Production FDA UDI

Identifiers

Primary DI / UDI-DI: B297KROUPT5800 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

Yes

FDA UDI

Category: Reverse-osmosis water purification system

Medical Reverse Osmosis by Speciality Water Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Speciality Water Technology

Sources (1)

FDA UDI 9df876b3-1dac-435f-b4d3-5cc5963abae6 34 fields · synced May 31, 2026