Rapicide OPA/28 Test Strips

Basic Information

• Brand Name: Rapicide OPA/28 Test Strips
• Primary DI: 10677964100953
• Version / Model: ML02-0136
• Company Name: MEDIVATORS INC.
• Labeler DUNS: 068199363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-02-26
• Public Version: 6
• Public Version Date: 2023-10-16
• Public Version Status: Update
• Public Device Record Key: 5726b50e-2c4d-4e8f-9ea0-f9715e16668f

Device Characteristics

• Single Use: No
• 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
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46945	Ortho-phthalaldehyde (OPA) device disinfectant 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 ortho-phthalaldehyde (OPA) in a device disinfectant solution after preparation to ensure disinfectant properties. It is used to prevent diluting the disinfectant 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	30677964100957	GS1	Box	2	In Commercial Distribution
Primary	10677964100953	GS1
Unit of Use	00677964100956	GS1

Storage Conditions

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