Tristel Test Strips

GUDID 05060171914686

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). A vial/bottle of 50 test strips. Stopwatch. Polyethylene container. 10ml measure syringe. User Guide.

TRISTEL SOLUTIONS LIMITED

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Primary Device ID05060171914686
NIH Device Record Key79e898b4-1853-4904-8510-91740b95794b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTristel Test Strips
Version Model Number45-13
Company DUNS235192791
Company NameTRISTEL SOLUTIONS LIMITED
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060171914686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QWSFoam Or Gel Chemical Sterilant/High Level Disinfectant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-11
Device Publish Date2024-04-03

On-Brand Devices [Tristel Test Strips]

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

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