AccessGUDID - DEVICE: Tri-Kleen (00866849000409)

GUDID

Device Identifier (DI) Information

Brand Name: Tri-Kleen
Version or Model: 400UV
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TRI-DIM FILTER CORPORATION

Primary DI Number: 00866849000409
Issuing Agency: GS1
Commercial Distribution End Date: September 04, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 191408400 *Terms of Use

Device 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
18113	High-efficiency filter air cleaner, mobile	A mains electricity (AC-powered) device that uses a combination of a prefilter and a high-efficiency particulate air (HEPA) filter to remove 99.97% of particles greater than 0.3 microns. This device is frequently used to prevent the transmission of tuberculosis (TB) and other diseases caused by airborne pathogens. It is designed to be moved from one location to another.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRF	Cleaner, Air, Medical Recirculating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984116	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b4117cc-ed64-4689-9068-36eb5e4c87c9
Public Version Date: January 16, 2020
Public Version Number: 5
DI Record Publish Date: September 05, 2017