SteriChek® Residual Peroxide Reagent Strips 821971

GUDID 00851575007075

Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.

HACH COMPANY

Hydrogen peroxide device disinfectant/sterilant test strip

• Primary Device ID: 00851575007075
• NIH Device Record Key: f71b3028-cca5-4ef7-ab9e-2acecbecf54b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriChek® Residual Peroxide Reagent Strips
• Version Model Number: 811905
• Catalog Number: 821971
• Company DUNS: 091381780
• Company Name: HACH COMPANY
• Device Count: 1200
• 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

Device Dimensions

• Width: 0.2 Inch
• Width: 0.2 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851575007037 [Unit of Use]
GS1	00851575007075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974798

FDA Product Code

• LIF: Dialyzer Reprocessing System

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

• 00851575007389 - Stericide Peroxide Reagent Strips: 2020-04-22 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis
• 00851575007020 - SteriChek® Residual Chlorine Reagent Strips: 2018-09-12 Reagent test strip for measuring the concentration of residual chlorine (i.e. from chlorine bleach) in rinse water following dis
• 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: 2018-09-12Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.
• 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.