SteriChek® Residual Peroxide Reagent Strips

Basic Information

• Brand Name: SteriChek® Residual Peroxide Reagent Strips
• Primary DI: 00851575007075
• Version / Model: 811905
• Catalog Number: 821971
• Company Name: HACH COMPANY
• Labeler DUNS: 091381780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1200
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2018-09-12
• Public Version Status: Update
• Public Device Record Key: f71b3028-cca5-4ef7-ab9e-2acecbecf54b

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
LIF	Dialyzer Reprocessing System	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58107	Hydrogen peroxide device disinfectant/sterilant test strip	A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of hydrogen peroxide (H2O2) in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851575007075	GS1
Unit of Use	00851575007037	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974798	000

Device Sizes

Type	Value	Unit	Text
Length	3.25	Inch
Width	0.2	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
• Type: Storage Environment Temperature
• Temperature Range: 60 – 90 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 60 – 90 Degrees Fahrenheit