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The Serim™ DISINTEK™ PA Test Strip is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in the high-level disinfectant RAPICIDE™ PA HLD solution, is above the 850 ppm PAA minimum recommended concentration (MRC) established for RAPICIDE™ PA HLD at both 30°C and 20°C.

The device is a qualitative, single use, reagent chemical indicator made up of a 0.2-inch x 0.2-inch indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration established for RAPICIDE™ PA High-Level Disinfectant. The indicator pad is affixed to one end of a 3.25-inch by 0.2-inch white plastic handle.

The RAPICIDE™ PA Test Strips are chemical indicators used after the disinfection cycle to ensure that the RAPICIDE™ PA High-Level Disinfectant solution is met the minimum recommended concentration of 850ppm peracetic acid. The RAPICIDE PA Test Strips are designed for use by trained personnel who reprocess endoscopes and their accessories in facilities where endoscopies are performed.

Rapicide PA High-Level Disinfectant Test Strip has the ability to measure the disinfectant use solution concentration above 850 ppm Peracetic Acid (PAA). This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high-level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, blue grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black after contact with solution at concentrations of 1100 ppm ± 20 ppm PAA.

The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: **Steam Sterilization Cycles:** - 250°F/121°C, 30 minutes Gravity - 270°F/132°C, 4 minutes Dynamic Air Removal - 270°F/132°C, 5 minutes Dynamic Air Removal - 270°F/132°C, 6 minutes Dynamic Air Removal - 270°F/132°C, 7 minutes Dynamic Air Removal - 270°F/132°C, 8 minutes Dynamic Air Removal - 270°F/132°C, 9 minutes Dynamic Air Removal - 270°F/132°C, 10 minutes Dynamic Air Removal - 270°F/132°C, 15 minutes Gravity - 273°F/134°C, 4 minutes Dynamic Air Removal - 275°F/135°C, 3 minutes Dynamic Air Removal - 275°F/135°C, 10 minutes Gravity **Steam Sterilization Cycles (IUSS):** - 270°F/132°C, 4 minutes Dynamic Air Removal - 270°F/132°C, 3 minutes Gravity - 270°F/132°C, 10 minutes Gravity - 275°F/135°C, 3 minutes Dynamic Air Removal - 275°F/135°C, 3 minutes Gravity - 275°F/135°C, 10 minutes Gravity

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack, pouch, container, tray or other containment device in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers. The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.

The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. Minimum Stated Values as determined in a resistometer: SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.

The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white polyester substrate with acrylic adhesive married to a paper substrate. The paper substrate (with acrylic adhesive) has True Indicating water-based steam indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed. After printing, the top layer of the Type 5 Integrating Indicator strip is covered with a clear colorless polyester laminate with acrylic adhesive. The Integrating Indicators have been designed for Steam sterilization processes, ensuring the effectiveness of sterilization by monitoring all critical process variables (time, temperature and steam). The pink indicating ink was developed to turn to dark and conceal the word "NOT" when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of a 105 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer).

Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile. The Autoclave Indicator Tape can be used in the following steam sterilization cycles: 1. Gravity: 121°C, 30 minutes 2. Vacuum assisted (pre-vacuum): 134°C, 4 minutes EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile. The EO Indicator Tape can be used in the following EO sterilization cycle: 55°C, 762mg/l EO, 40~80%RH, 4 hours exposure

Autoclave Indicator Tape is a single chemical indicator designed for steam sterilizing monitoring. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial yellow color of the indicator ink on the autoclave indicator tape changes to Black. If no color change occurs, it may indicate that the autoclave indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile. EO Indicator Tape is single chemical indicator designed for use in ethylene oxide sterilizing processes. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial orange color of the indicator ink on the EO indicator tape changes to green. If no color change occurs, it may indicate that the EO indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.

The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant. The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator color changes from the start to the pass color. See reference colors on the bottle.

The enspire 3000 Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. The product is manufactured by application of the indicator ink by screen printing to a substrate with the indicator ink printed thereon. A clear, sterilant-permeable polyether block amide laminate is adhesively bonded to the polypropylene strip following printing of the ink, completely covering the ink. Modification for Which Clearance is Being Sought: There were no physical changes to the device and are no new indications for use. The labeling was modified to include an additional pass reference color and a gradient between the original and new pass reference colors to improve user interpretation of chemical indicator.

The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles: Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal 273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal IUSS 270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS 275°F/135°C, 3 minutes Dynamic Air Removal IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C

The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014. It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.

The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. Use the Kem Medical Lead-free Chemical Indicators for Steam Sterilization in the validated steam sterilization processes described below: *Gravity: 121 C/250 F - 30 minutes (wrapped/porous) *Gravity: 132 C/270 F - 3 minutes (unwrapped/nonporous) *Gravity: 132 C/270 F - 15 minutes (wrapped/porous) *Gravity: 135 C/275 F - 3 minutes (unwrapped/nonporous) * Gravity: 135 C/275 F - 10 minutes (wrapped/porous or unwrapped/nonporous, mixed load) * Vacuum assisted (prevacuum): 132 C/270 F - 3 minutes (unwrapped/nonporous) * Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes (wrapped/porous) * Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes (wrapped/porous) *Vacuum assisted (prevacuum): 135 C/275 F - 3 minutes (wrapped/porous or unwrapped/nonporous, mixed load)

The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. They are Type 1 Process Indicators per ISO 11140-1:2014 Sterilization of healthcare products-Chemical Indicators - Part 1 General Requirements, consisting of chemical indicator ink and paper substrate with a visual color change from light color (white/off-white) to dark color (cocoa/black) when exposed to a steam sterilization process. The Kem Medical Lead-free Chemical Indicators for Steam Sterilization consist of indicator ink printed on a paper substrate with or without adhesive. The indicator ink is lead free. An example of this indicator is the ink printed onto adhesive-coated paper for autoclave labels, or "dots", which are removed from a poly or paper backing for use. Kem Medical manufactures in various shapes and sizes printed on paper substrates with and without adhesive on the underside, and with or without labeling on each individual indicator.

The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches. The tape may be used in the following sterilization cycles: · Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems. · Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALL Clear Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

The CELERITY HP Indicator Tape (Indicator Tape) is a ¾'' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.