Tristel Test Strips

Basic Information

• Brand Name: Tristel Test Strips
• Primary DI: 05060171914693
• Version / Model: 45-10
• Company Name: TRISTEL SOLUTIONS LIMITED
• Labeler DUNS: 235192791
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-03
• Public Version: 2
• Public Version Date: 2024-04-16
• Public Version Status: Update
• Public Device Record Key: 59cef193-581c-4412-b4c2-17ad1a749cee

Device Description

The Tristel Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of the Tristel ULT high level disinfectant foam is above or below the minimum recommended concentration (MRC)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QWS	Foam Or Gel Chemical Sterilant/High Level Disinfectant	General Hospital	880.6886	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58056	Medical device disinfection solution test strip	A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060171914693	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN220041	000