SteriChek® Peracetic Acid Reagent Strips 811906

GUDID 00851575007150

Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.

HACH COMPANY

Peracetic acid device disinfectant/sterilant test strip

• Primary Device ID: 00851575007150
• NIH Device Record Key: 47724838-841c-462f-899e-f57e6e133cd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriChek® Peracetic Acid Reagent Strips
• Version Model Number: 811906
• Catalog Number: 811906
• Company DUNS: 091381780
• Company Name: HACH COMPANY
• Device Count: 600
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com
• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com
• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com
• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com
• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com
• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com
• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com
• Phone: 1-970-278-4951
• Email: etscustomerservice@hach.com

Device Dimensions

• Length: 3.25 Inch
• Length: 3.25 Inch
• Width: 0.2 Inch
• Length: 3.25 Inch
• Width: 0.2 Inch
• Length: 3.25 Inch
• Width: 0.2 Inch
• Length: 3.25 Inch
• Width: 0.2 Inch
• Length: 3.25 Inch
• Width: 0.2 Inch
• Length: 3.25 Inch
• Width: 0.2 Inch
• Length: 3.25 Inch
• Width: 0.2 Inch
• Length: 3.25 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851575007082 [Unit of Use]
GS1	00851575007150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980164

FDA Product Code

• MSY: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2016-09-23

Devices Manufactured by HACH COMPANY

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• 00851575007044 - SteriChek® Peroxide Reagent Strips: 2018-09-12 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis
• 00851575007051 - SteriChek® Total Chlorine Test Kit: 2018-09-12 Reagent test kit used to measure low levels of total chlorine in feed water used to prepare dialysate.
• 00851575007068 - Sterichek® Total Chlorine Test Kit Refill: 2018-09-12 DPD reagent powder pillows refill, used with reagent test kit to measure low levels of total chlorine in feed water used to prep
• 00851575007075 - SteriChek® Residual Peroxide Reagent Strips: 2018-09-12 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis
• 00851575007105 - SteriChek® Blood Leak Reagent Strips: 2018-09-12 Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure.
• 00851575007129 - SteriChek® Blood Leak Reagent Strips: 2018-09-12 Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure.