Portable D.I.Controller

FDA UDI

Class II (US FDA UDI)

by Speciality Water Technology

Identity

Trade Name: Portable D.I.Controller FDA UDI
Generic Name: Combination water purification system FDA UDI
Device Name: Portable DI Controller w/ Self Return Product Divert Valve, Remote Alarm Station and DI Rinse Program. Mutable 180 Seconds. Meets AAMI 2015 Standards. FDA UDI
Model / Reference: A-MT-DI-5150-SKID FDA UDI
Description: Portable DI Controller w/ Self Return Product Divert Valve, Remote Alarm Station and DI Rinse Program. Mutable 180 Seconds. Meets AAMI 2015 Standards. FDA UDI

Identifiers

Primary DI / UDI-DI: B297AMTDI5150SKID0 FDA UDI
FDA Product Code: FIP FDA UDI
GMDN Term: Combination 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: Combination water purification system

Portable D.I.Controller 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 27b6f8ec-af62-4a19-bebb-31c3af6a7ee4 34 fields · synced Jun 6, 2026