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 ID: 00866849000416
• NIH Device Record Key: 9ed0d9ad-7bad-400f-b94b-7ecb214c40fe
• Commercial Distribution Discontinuation: 2018-09-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tri-Kleen
• Version Model Number: 400
• Company DUNS: 191408400
• Company Name: TRI-DIM FILTER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00680418000016 [Primary]
GS1	00866849000416 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984116

FDA Product Code

• FRF: Cleaner, Air, Medical Recirculating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-16
• Device Publish Date: 2017-09-05

On-Brand Devices [Tri-Kleen]

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