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510(k) Data Aggregation
K Number
K232103Device Name
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
Manufacturer
Terragene SA
Date Cleared
2024-04-05
(266 days)
Product Code
QKM, JOJ, OKM
Regulation Number
880.2800Why did this record match?
Product Code :
QKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Terragene® Chemdye® Multivariable Chemical Indicator (CD40) is a multivariable chemical indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® NX Sterilization System (Standard and Advanced cycles).
- · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
- · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
- · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
The chemical indicator changes from purple to green to indicate that the conditions of the cycle have been met.
Terragene® Chemical Process Indicator (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® NX Sterilization System (Standard and Advanced cycles).
- · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
- · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
- · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer (Cycle 1).
The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.
Terragene® Cintape® Chemical Process Indicator Tape (CT40) is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® NX Sterilization System (Standard and Advance cycles).
- · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
- · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
- · Sterrad® 100NX with ALLCrear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer (Cycle 1).
The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
Device Description
Not Found
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K Number
K212022Device Name
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Manufacturer
3M Company
Date Cleared
2022-04-20
(295 days)
Product Code
QKM
Regulation Number
880.2800Why did this record match?
Product Code :
QKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles:
- STERRAD 100S® Sterilization System
- STERRAD NX® Sterilization System (Standard and Advanced cycles)
- STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
- STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
- STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
- V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
- V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
- V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
- V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
- V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
- V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
- STERIZONE® VP4 Sterilizer (Cycle 1)
Device Description
The 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.
Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue to pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.
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K Number
K213262Device Name
CELERITY HP Chemical Indicator
Manufacturer
Steris Corporation
Date Cleared
2022-01-07
(99 days)
Product Code
QKM
Regulation Number
880.2800Why did this record match?
Product Code :
QKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
Device Description
The Celerity™ HP Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for multivariable indicator claims.
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K Number
K203284Device Name
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
Manufacturer
3M Company
Date Cleared
2020-12-07
(28 days)
Product Code
QKM
Regulation Number
880.2800Why did this record match?
Product Code :
QKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).
Device Description
The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.
Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.
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K Number
K193110Device Name
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Manufacturer
3M Health Care
Date Cleared
2020-03-13
(122 days)
Product Code
QKM
Regulation Number
880.2800Why did this record match?
Product Code :
QKM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX ® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).
Device Description
The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.
Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.
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