Tristel Test Strips

GUDID 05060171914693

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)

TRISTEL SOLUTIONS LIMITED

Peracetic acid device disinfectant/sterilant test strip

• Primary Device ID: 05060171914693
• NIH Device Record Key: 59cef193-581c-4412-b4c2-17ad1a749cee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tristel Test Strips
• Version Model Number: 45-10
• Company DUNS: 235192791
• Company Name: TRISTEL SOLUTIONS LIMITED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060171914693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220041

FDA Product Code

• QWS: Foam Or Gel Chemical Sterilant/High Level Disinfectant

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-11
• Device Publish Date: 2024-04-03

On-Brand Devices [Tristel Test Strips]

• 05060171914693: The Tristel Test Strips are semi-quantitative chemical indicators used to determine whether the
• 05060171914686: The Tristel Test Strips are semi-quantitative chemical indicators used to determine whether the