Cidex

Basic Information

• Brand Name: Cidex
• Primary DI: 20705037007865
• Version / Model: 2927
• Catalog Number: 2927
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Labeler DUNS: 947451626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: 42a0b37f-6aa0-472a-8947-1ddad977fc02

Device Description

Cidex Activated Dialdehyde Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOJ	Indicator, physical/chemical sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47056	Glutaraldehyde 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 glutaraldehyde 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
Package	30705037007862	GS1	Case	2	In Commercial Distribution
Primary	20705037007865	GS1
Unit of Use	80705037007867	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K922481	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius