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510(k) Data Aggregation
K Number
K974062Device Name
MEDSCI 3% GLUTARALDEHYDE
Manufacturer
Date Cleared
1998-09-02
(310 days)
Product Code
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
MEDSCI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MedSCI 3% glutaraldehyde may be used to sterilize or high-level disinfect reusable medical devices that are heat labile or otherwise incompatible with other biologically monitored methods of sterilization. MedSCI 3% glutaraldehyde is intended to be used by healthcare practitioners, e.g., doctors, nurses and dentists in various healthcare facilities, e.g., hospitals, doctors offices and dentist offices.
Germicidal Level of Activity of MedSCI 3% glutaraldehyde as a:
Sterilant. MedSCI 3% glutaraldehyde is a sterilant when reusable medical devices are immersed for 10 hours at 25°C. It may be used or reused for a maximum of 28 days if the glutaraldehyde concentration is above the Minimum Effective Concentration (MEC) of 1.8% as determined by the 3M Cold Sterilog® 2.1% Glutaraldehyde Monitor.
High-Level Disinfectant. MedSCI 3% glutaraldehyde is a high-level disinfectant when reusable medical devices are immersed for 25 minutes at 25° C. It may be used or reused for a maximum of 28 days if the glutaraldehyde concentration is above the Minimum Effective Concentration (MEC) of 1.8% as determined by the 3M Cold Sterilog® 2.1% Glutaraldehyde Monitor.
Device Description
MedSCI 3% glutaraldehyde is an activated glutaraldehyde liquid chemical sterilant and high-level disinfectant when used according to the Directions for Use. The active ingredient in MedSCI 3% glutaraldehyde is glutaraldehyde in a nominal concentration of 3.0%. In addition, the activated solution contains buffers, wetting agent, rust inhibitor, fragrance and a dye that changes the solution green upon activation thereby indicating readiness for use.
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