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 Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution 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
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• 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.