Tri-Kleen

GUDID 00866849000416

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

TRI-DIM FILTER CORPORATION

High-efficiency filter air cleaner, mobile
Primary Device ID00866849000416
NIH Device Record Key9ed0d9ad-7bad-400f-b94b-7ecb214c40fe
Commercial Distribution Discontinuation2018-09-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTri-Kleen
Version Model Number400
Company DUNS191408400
Company NameTRI-DIM FILTER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100680418000016 [Primary]
GS100866849000416 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRFCleaner, Air, Medical Recirculating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-16
Device Publish Date2017-09-05

On-Brand Devices [Tri-Kleen]

00866849000416Tri-Kleen Air Purification System, 115 Volt, 2.5 Amp, 60 Hz. Electrical Safety: CAN/CSA C22.2 No
00866849000409Tri-Kleen Air Purification System, 115 Volt, 2.5 Amp, 60 Hz. Electrical Safety: CAN/CSA C22.2 No

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