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510(k) Data Aggregation
K Number
K140703Device Name
OPA 30 SOLUTION
Manufacturer
CIDEN TECHNOLOGIES LLC
Date Cleared
2014-08-19
(152 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
CIDEN TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OPA 30 Solution is a high level disinfectant for reprocessing heat sensitive semi-critical medical devices for which sterilization is not suitable, and when used according to the Directions for Use. OPA 30 Solution may be used of reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20°C (68°F), for a reuse period not to exceed 30 days. OPA 30 Solution may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25°C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25℃ (77ºF), for a reuse period not to exceed 14 days.
Device Description
The OPA 30 Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30° C (59-86° F) for its labeled shelf life of 24 months. OPA 30 Solution may be used or reused for manual (up to 30 days) or automated reprocessing (up to 14 days), according to the Directions for Use. OPA 30 Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.
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K Number
K070627Device Name
OPACIDEN SOLUTION
Manufacturer
CIDEN TECHNOLOGIES LLC
Date Cleared
2007-08-02
(149 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
CIDEN TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opaciden Solution is a high level disinfectant for reprocessing heat-sensitive medical devices for which sterilization is not suitable, and when used according to the Directions for Use. Opaciden may be used or reused at or above its Minimum Recommended Concentration (MRC) of 0.3%, as determined by Opaciden OPA Reagent Strips, in manual reprocessing with an immersion time of at least 12 minutes at a minimum of 20° C (68° F), for a reuse period not to exceed 14 days. Opaciden may also be used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25° C), at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with an immersion time of at least 5 minutes at a minimum of 25° C (77° F), for a reuse period not to exceed 14 days.
Device Description
Opaciden Solution is a clear, pale blue liquid with a pH of 7.5. It contains 0.60% ortho-Phthalaldehyde in an aqueous base containing buffers, chelating agents and a corrosion inhibitor. It is stable at 15-30°C (59-86°F) for its labeled shelf life. The product may be used or reused (up to 14 days) for manual or automated reprocessing, according to the Directions for Use. Opaciden Solution must be used at or above its Minimum Recommended Concentration (MRC), as determined by Opaciden OPA Reagent Strips, with the immersion time and temperature specified for the disinfection method.
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