Rapicide PA Test Strips

Basic Information

• Brand Name: Rapicide PA Test Strips
• Primary DI: 10724995245525
• Version / Model: ML020118
• Catalog Number: ML020118
• Company Name: MEDIVATORS INC.
• Labeler DUNS: 068199363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-06-10
• Public Version: 1
• Public Version Date: 2025-06-18
• Public Version Status: New
• Public Device Record Key: fff6f50f-d745-471b-8f4b-ff0070c24e05

Device Description

Rapicide PA Test Strips

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
58056	Medical device disinfection solution 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 the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995245523	GS1	Box	2	In Commercial Distribution
Primary	10724995245525	GS1
Unit of Use	00724995245528	GS1
Previous	10677964064071	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152394	000
K251048	000