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Tri-Kleen

FDA UDI

Class II (US FDA UDI)

by Tri-Dim Filter Corporation

Identity

Trade Name
Tri-Kleen FDA UDI
Generic Name
High-efficiency filter air cleaner, mobile FDA UDI
Device Name
Tri-Kleen Air Purification System, 115 Volt, 2.5 Amp, 60 Hz. Electrical Safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Mechanical safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Made in Canada FDA UDI
Model / Reference
400UV FDA UDI
Description
Tri-Kleen Air Purification System, 115 Volt, 2.5 Amp, 60 Hz. Electrical Safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Mechanical safety: CAN/CSA C22.2 No. 113:2015-05 & UL 507:1999/R2012-06. Made in Canada FDA UDI

Identifiers

Primary DI / UDI-DI
00866849000409 FDA UDI
510(k) Number
K984116 FDA UDI
FDA Product Code
FRF FDA UDI
GMDN Term
High-efficiency filter air cleaner, mobile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5045 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Tri-Kleen by Tri-Dim Filter Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K984116 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tri-Dim Filter Corporation

Sources (1)

  • FDA UDI 6b4117cc-ed64-4689-9068-36eb5e4c87c9 35 fields · synced May 30, 2026