FlexLab

GUDID 07640172340004

The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sa

Inpeco SA

Specimen processing instrument IVD, automated

• Primary Device ID: 07640172340004
• NIH Device Record Key: 0db7ccee-b2bd-498f-9d67-15e52943bb12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexLab
• Version Model Number: FLX
• 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	07640172340004 [Primary]
GS1	7640172340509 [Package]; Package: [1 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Inpeco SA

• 07640172344002 - FlexLab X: 2024-08-07 The FlexLab X automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling
• 07640172343012 - ProTube: 2022-02-16 ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is
• 07640172341001 - Accelerator a3600: 2021-11-12 The Accelerator a3600 automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample
• 07640172342008 - Aptio Automation: 2021-11-12 The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in
• 07640172343005 - ProTube: 2020-09-21 The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collectio
• 07640172340004 - FlexLab: 2018-07-06The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sa
• 07640172340004 - FlexLab: 2018-07-06 The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling i
• 7640172341506 - Accelerator a3600: 2018-07-06 The Accelerator a3600 automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample
• 7640172342503 - Aptio Automation: 2018-07-06 The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in