PeraChek

Basic Information

• Brand Name: PeraChek
• Primary DI: 00898021000242
• Version / Model: 1701-01
• Catalog Number: 1701-01
• Company Name: Angelini Pharma Inc.
• Labeler DUNS: 078843940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-23
• Public Version: 4
• Public Version Date: 2023-02-15
• Public Version Status: Update
• Public Device Record Key: e5e52977-ef04-4b6d-a861-2d86b449ef23

Device Description

Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.

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
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	Gastroenterology, Urology	876.5665	2
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	00898021000242	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K980164	000

Device Sizes

Type	Value	Unit	Text
Width	0.2	Inch
Length	3.25	Inch

Storage Conditions

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