Aptio Automation

GUDID 07640172342008

The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation.

Inpeco SA

Specimen processing instrument IVD, automated

• Primary Device ID: 07640172342008
• NIH Device Record Key: 49495970-ae4e-408b-b7e2-64b74b4417f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aptio Automation
• Version Model Number: AP2
• Company DUNS: 484880690
• Company Name: Inpeco SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640172342008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121012

FDA Product Code

• CEM: Electrode, Ion Specific, Potassium

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-12
• Device Publish Date: 2016-09-24

On-Brand Devices [Aptio Automation]

• 7640172342503: The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical
• 07640172342008: The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical