Aptiva® System Cleaning Solution Kit

GUDID 00195126000871

The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module (OM) and flush the system.

INOVA DIAGNOSTICS, INC.

Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD Instrument/analyser cleaning agent IVD

• Primary Device ID: 00195126000871
• NIH Device Record Key: 2461cb2f-de70-4ce3-bfe0-38fe918764a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptiva® System Cleaning Solution Kit
• Version Model Number: AC1003
• Company DUNS: 188354831
• Company Name: INOVA DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: TechSupport.na@werfen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195126000871 [Primary]
GS1	08430793041140 [Previous]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-26
• Device Publish Date: 2024-03-18

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