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510(k) Data Aggregation
K Number
K200096Device Name
Crosstex VH2O2 Chemical Indicators
Manufacturer
Crosstex International, Inc. (A Cantel Medical Company)
Date Cleared
2021-07-15
(546 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Crosstex International, Inc. (A Cantel Medical Company)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.
Device Description
The Crosstex VH2O2 Chemical Indicators are intended for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX, and Sterilucent™ PSD-85 sterilization processes. The Crosstex VH2O2Chemical Indicators are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Chemical indicators change to a color of blue after exposure to vaporized hydrogen peroxide. Colors other than blue such as yellow/green should be treated as a process failure.
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