SteriChek® Total Chlorine Test Kit

Basic Information

• Brand Name: SteriChek® Total Chlorine Test Kit
• Primary DI: 00851575007051
• Version / Model: 811902
• Catalog Number: 811902
• Company Name: HACH COMPANY
• Labeler DUNS: 091381780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-11-23
• Public Version: 4
• Public Version Date: 2018-09-12
• Public Version Status: Update
• Public Device Record Key: ed25753c-488d-4939-93f2-156007783f1c

Device Description

Reagent test kit used to measure low levels of total chlorine in feed water used to prepare dialysate.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62445	Haemodialysis dialysate water chlorine test kit	A collection of reagents and other associated materials intended to be used to rapidly indicate, through colour change, the concentration of total chlorine in water used to prepare dialysate solution for haemodialysis. It includes test tubes, a colorimetric reagent (e.g., DPD, potassium iodide) which produces a colour change upon reaction with chlorine/chloramine, and a visual standard for colour comparison. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851575007051	GS1
Unit of Use	00851575007013	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K983997	000

Device Sizes

Type	Value	Unit	Text
Weight	0.150	Gram

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 50 – 77 Degrees Fahrenheit