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Found 9 results
510(k) Data Aggregation
K Number
K133267Device Name
DANA REUSABLE TEST PACK
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2014-02-11
(110 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with a 3M TM Attest ™ Super Rapid Readout Biological Indicator 1492V along with or without SteriScan Integrators.
Device Description
Not Found
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K Number
K130135Device Name
DANA REUSABLE BI TEST PACK
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2013-11-25
(311 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam along with or without SteriScan Integrators.
Device Description
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K Number
K120592Device Name
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2013-02-27
(365 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dana Reusable Bowie Dick Type Test Pack, when used with a Dana Bowie Dick indicator, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.
Device Description
Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators
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K Number
K110253Device Name
REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2011-04-29
(91 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum 4 minute steam sterilization cycles with the Dana Emulating Indicator cleared by FDA under K100891.
Device Description
Reusable Integrator Test Pack for Dana Emulating Indicator.
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K Number
K103321Device Name
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2011-02-16
(96 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.
Device Description
Reusable Biological Indicator Test Pack for Steam Sterilization.
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K Number
K100891Device Name
DANA EMULATING INDICATOR
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2011-01-13
(288 days)
Product Code
JOJ, JQJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met. Critical Parameters in a standard hospital pre-vacuum steam sterilizer Temperature : 270°F (132°C) Time: 4 Minutes
Device Description
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K Number
K102761Device Name
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2010-12-20
(88 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dana reusable challenge test pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SteriScan Integrators.
Device Description
Reusable SteriScan Integrator Test Pack for Steam
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K Number
K092944Device Name
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2010-03-18
(175 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dana reusable test pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with 3M's 1292 Rapid Readout Biological Indicators along with or without SteriScan Integrators.
Device Description
Reusable Biological Indicator and Integrator Test Pack for Steam Sterilization.
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K Number
K012195Device Name
STEAM STERILIZATION INTERGRATOR
Manufacturer
DANA PRODUCTS, INC.
Date Cleared
2002-05-07
(298 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
DANA PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.
Device Description
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