Sterichek® Total Chlorine Test Kit Refill 811903

GUDID 00851575007068

DPD reagent powder pillows refill, used with reagent test kit to measure low levels of total chlorine in feed water used to prepare dialysate.

HACH COMPANY

Haemodialysis dialysate water chlorine test kit

• Primary Device ID: 00851575007068
• NIH Device Record Key: e9e477f0-3d73-43d5-add6-3728d3a21c5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterichek® Total Chlorine Test Kit Refill
• Version Model Number: 811902
• Catalog Number: 811903
• Company DUNS: 091381780
• Company Name: HACH COMPANY
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

• Weight: 0.15 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851575007013 [Unit of Use]
GS1	00851575007068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983997

FDA Product Code

• FIP: Subsystem, Water Purification

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: 2016-11-23

Devices Manufactured by HACH COMPANY

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• 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: 2018-09-12DPD reagent powder pillows refill, used with reagent test kit 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.