Aptiva® Optical Cleaning Solution

Basic Information

• Brand Name: Aptiva® Optical Cleaning Solution
• Primary DI: 08430793041140
• Version / Model: AC1003
• Company Name: INOVA DIAGNOSTICS, INC.
• Labeler DUNS: 188354831
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-11
• Public Version: 2
• Public Version Date: 2026-04-02
• Public Version Status: Update
• Public Device Record Key: f004b7c3-58d5-4a85-ba58-083ed45252c4
• Distribution End Date: 2024-11-30

Device Description

The Aptiva Optical Cleaning Solution is for use on the Inova Diagnostics Aptiva Digital Multi-Analyte System to clean the instrument Optical Module (OM)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63377	Instrument/analyser cleaning agent IVD	A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to in vitro diagnostic devices (e.g., analysers, laboratory instruments, other types of laboratory devices) for pre-cleaning and/or cleaning to remove organic compounds such as blood proteins prior to disinfection or sterilization. It is typically loaded on-board automated or semi-automated instruments for internal cleaning. It typically includes a detergent, and some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08430793041140	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius