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Tristel Test Strips

Primary DI
05060171914693
Brand
Tristel Test Strips
Company
TRISTEL SOLUTIONS LIMITED
Model
45-10
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)
Published
2024-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QWSFoam Or Gel Chemical Sterilant/High Level Disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWSFoam Or Gel Chemical Sterilant/High Level DisinfectantGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220041000Tristel Duo ULTTristel Solutions Limited2023-06-02QWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060171914693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060171914693050601719146935060171914693

GMDN Terms#

Term, Definition table
TermDefinition
Peracetic acid device disinfectant/sterilant test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of peracetic acid in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
235192791
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060171915720Tristel OPHTSL025126 (case of 2 boxes)2025-07-17
05060171915706Tristel OPHTristel OPH Wipes2025-07-17
05060171915713Tristel OPHTSL025126 (case of 2 boxes)2025-07-17
05060171915744Tristel OPHTristel OPH Foam2025-07-17
05060171914686Tristel Test Strips45-132024-04-03
05060171914679Tristel ULT45-25 (case of 2 boxes)2023-10-16
05060171914549Tristel ULTTristel ULT Foam2023-10-16
05060171914556Tristel ULTTristel ULT Wipes2023-10-16
05060171914532Tristel ULT45-25 (case of 2 boxes)2023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060171915720Tristel OPHTRISTEL SOLUTIONS LIMITEDQWS2025-07-17
05060171915706Tristel OPHTRISTEL SOLUTIONS LIMITEDQWS2025-07-17
05060171915713Tristel OPHTRISTEL SOLUTIONS LIMITEDQWS2025-07-17
05060171915744Tristel OPHTRISTEL SOLUTIONS LIMITEDQWS2025-07-17
05060171914686Tristel Test StripsTRISTEL SOLUTIONS LIMITEDQWS2024-04-03
05060171914679Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16
05060171914549Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16
05060171914556Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16
05060171914532Tristel ULTTRISTEL SOLUTIONS LIMITEDQWS2023-10-16