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The Reliance™ CI Process Indicator is intended for routine monitoring of the Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance™ CI Process Indicator is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.

The Reliance CI is a single-use chemical indicator with indicator ink printed on one end that was developed to monitor the peracetic acid (PAA) dose at the point of use in a Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance CI shows an incomplete color change when exposed to peracetic acid at a dose of 9,000 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle. The Reliance CI changes color from orange to white (colorless) when exposed to peracetic acid at a dose of 11,500 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle.

The Albert Browne Ltd. VERIFY® STEAM and EO Load Record Card are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121℃ to 135℃ (250°F to 275°F) or an ethylene oxide sterilization process.

The proposed VERIFY® STEAM and EO Load Record Card is a 5"x3" card containing space for recording information regarding the load to be processed and two indicator ink strips applied to the card using a rotary screen printing method. The indicator ink strips are steam and ethylene oxide-sensitive indicators that change color following exposure to the appropriate sterilant.

The Verify® Dry Heat Label is a process indicator that undergoes a visual color change from amber to black when exposed to dry heat in a temperature range of 160°C to 180°C.

The proposed Verify® Dry Heat Label consists of indicator ink applied to a substrate using a rotary screen printing method. When exposed to dry heat in the temperature range of 160°C to 180°C the indicator ink changes color from amber to black. The indicator is not intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a dry heat process.

The Albert Browne Ltd. Verify Gravity Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions: - 270°F (132°C), 3 min. flash gravity steam sterilization . - 270°F (132°C), 10 min. flash gravity steam sterilization .

The proposed Albert Browne, Ltd. Verify Gravity Flash Integrator is a 22 mm x 143 mm strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The proposed integrator can be used to monitor 3 min. and 10 min. 132°C gravity flash steam sterilization cycles.

The Albert Browne Ltd. VERIFY® STEAM Value Indicators are process indicators that undergo a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

Similar to the parent Modified Browne Packaging and Label Steam Process Indicator, the proposed VERIFY® STEAM Value Indicators consists of indicator ink applied to a suitable substrate, i.e. packaging material, self-adhesive labels, tapes, tags, inserts, etc. Modifications to the parent indicator to produce the proposed VERIFY® STEAM Value Indicators included changes to the indicator ink composition, modification to the process used for application of the indicator ink to the substrates, and minor changes to the suite of compatible substrates. The modifications to the indicator ink composition were made to produce two variants with different color change schemes and improve the "printability" of the ink.

The Verify Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions: - 270°F (132°C), 10 min. flash gravity steam sterilization . - 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization .

The proposed Verify Flash Integrator is a polypropylene strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color.

The Verify® Self-Contained Biological Indicator may be used for installation testing and routine monitoring of the following steam sterilization cycle: - 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle . for packaged items

The proposed Verify® Self-Contained Biological Indicator (SCBI) is identical in components, design, materials, and manufacturing specifications to the predicate Verify® Self-Contained Biological Indicator (cleared in K855101 as the Assert™ Biological/Chemical Indicator). The SCBI consists of a plastic vial that contains a disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and an ampoule of culture media.

The Modified Browne Packaging and Label Steam Process Indicator (Modified Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 135°C (250°F to 275°F).

Like the parent Browne Packaging and Label Steam Indicator, the proposed Modified Packaging and Label Indicator consists of indicator ink applied to a suitable substrate using a flexographic printing method. When exposed to steam in the temperature range of 121°C to 135°C (250°F to 275°F), the indicator changes color. The parent indicator changed color from pink to purple. The color change for the proposed indicator is from pink to dark purple. Neither the proposed or parent indicator is intended to indicate that specific sterilization parameters have been met, but simply that the indicator has been exposed to a steam process.